Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension: 12-Month Results of a Randomized, Double-Masked Trial.

INTRODUCTION: This prospective, multicenter, randomized, double-masked pivotal phase 3 trial evaluated the efficacy and safety of the travoprost intracameral SE-implant (slow-eluting implant, the intended commercial product) and FE-implant (fast-eluting implant, included primarily for masking purposes) compared to twice-daily (BID) timolol ophthalmic solution, 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: The trial enrolled adult patients with OAG or OHT with an unmedicated mean diurnal intraocular pressure (IOP) of ≥ 21 and unmedicated IOP ≤ 36 mmHg at each diurnal timepoint (8 A.M., 10 A.M., and 4 P.M.) at baseline. The eligible eye of each patient was administered an SE-implant, an FE-implant or had a sham administration procedure. Patients who received an implant were provided placebo eye drops to be administered BID and patients who had the sham procedure were provided timolol eye drops to be administered BID. The primary efficacy endpoint, for which the study was powered, was mean change from baseline IOP at 8 A.M. and 10 A.M. at day 10, week 6, and month 3. Non-inferiority was achieved if the upper 95% confidence interval (CI) on the difference in IOP change from baseline (implant minus timolol) was < 1.5 mmHg at all six timepoints and < 1 mmHg at three or more timepoints. The key secondary endpoint was mean change from baseline IOP at 8 A.M. and 10 A.M. at month 12. Non-inferiority at month 12 was achieved if the upper 95% CI was < 1.5 mmHg at both timepoints. Safety outcomes included treatment-emergent adverse events (TEAEs) and ophthalmic assessments. RESULTS: A total of 590 patients were enrolled at 45 sites and randomized to one of three treatment groups: 197 SE-implant (the intended commercial product), 200 FE-implant, and 193 timolol. The SE-implant was non-inferior to timolol eye drops in IOP lowering over the first 3 months, and was also non-inferior to timolol at months 6, 9, and 12. The FE-implant was non-inferior to timolol over the first 3 months, and also at months 6 and 9. Of those patients who were on glaucoma medication at screening, a significantly greater proportion of patients in the SE- and FE-implant groups (83.5% and 78.7%, respectively) compared to the timolol group (23.9%) were on fewer topical glaucoma medications at month 12 compared to screening (P < 0.0001, chi-square test). TEAEs, mostly mild, were reported in the study eyes of 39.5% of patients in the SE-implant group, 34.0% of patients in the FE-implant group and 20.1% of patients in the timolol group. CONCLUSIONS: The SE-travoprost intracameral implant demonstrated non-inferiority to timolol over 12 months whereas the FE-implant demonstrated non-inferiority over 9 months. Both implant models were safe and effective in IOP lowering in patients with OAG or OHT. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03519386.

Phase 3 Randomized Clinical Trial of the Safety and Efficacy of Travoprost Intraocular Implant in Patients with Open-Angle Glaucoma or Ocular Hypertension.

PURPOSE: To evaluate the safety and intraocular pressure (IOP)-lowering efficacy of 2 models of the travoprost intraocular implant (fast-eluting [FE] and slow-eluting [SE] types) from 1 of 2 phase 3 trials (the GC-010 trial). DESIGN: Multicenter, randomized, double-masked, sham-controlled, noninferiority trial. PARTICIPANTS: Patients with open-angle glaucoma or ocular hypertension having an unmedicated baseline mean diurnal IOP (average of 8 am, 10 am, and 4 pm time points) of ≥ 21 mmHg, and IOP of ≤ 36 mmHg at each of the 8 am, 10 am, and 4 pm timepoints at baseline. METHODS: Study eyes were randomized to the travoprost intraocular implant (FE implant [n = 200] or SE implant [n = 197] model) or to timolol ophthalmic solution 0.5% twice daily (n = 193). MAIN OUTCOME MEASURES: The primary outcome was mean change from baseline IOP in the study eye at 8 am and 10 am, at each of day 10, week 6, and month 3. Safety outcomes included adverse events (AEs) and ophthalmic assessments. RESULTS: Mean IOP reduction from baseline over the 6 time points ranged from 6.6 to 8.4 mmHg for the FE implant group, from 6.6 to 8.5 mmHg for the SE implant group, and from 6.5 to 7.7 mmHg for the timolol group. The primary efficacy end point was met; the upper limit of the 95% confidence interval of the difference between the implant groups and the timolol group was < 1 mmHg at all 6 time points. Study eye AEs, most of mild or moderate severity, were reported in 21.5%, 27.2%, and 10.8% of patients in the FE implant, SE implant, and timolol groups, respectively. The most common AEs included iritis (FE implant, 0.5%; SE implant, 5.1%), ocular hyperemia (FE implant, 3.0%; SE implant, 2.6%), reduced visual acuity (FE implant, 1.0%; SE implant, 4.1%; timolol, 0.5%), and IOP increased (FE implant, 3.5%; SE implant, 2.6%; timolol, 2.1%). One serious study eye AE occurred (endophthalmitis). CONCLUSIONS: The travoprost intraocular implant demonstrated robust IOP reduction over the 3-month primary efficacy evaluation period after a single administration. The IOP-lowering efficacy in both implant groups was statistically and clinically noninferior to that in the timolol group, with a favorable safety profile. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Efficacy and Safety of the Travoprost Intraocular Implant in Reducing Topical IOP-Lowering Medication Burden in Patients with Open-Angle Glaucoma or Ocular Hypertension.

PURPOSE: A randomized, double-masked, multicenter, phase 2 trial to evaluate the long-term safety and efficacy of travoprost intraocular implant, an extended-release drug delivery system designed to provide uninterrupted sustained intraocular pressure (IOP)-lowering therapy, thereby reducing patient treatment burden and improving adherence with IOP-lowering medication. METHODS: Patients with open-angle glaucoma or ocular hypertension were administered a fast-eluting implant (FE implant, n = 51) and received twice-daily (BID) placebo eye drops, a slow-eluting (SE implant, n = 54) and received BID placebo eye drops, or underwent a sham surgical procedure and received BID timolol 0.5% (n = 49). IOP was measured at baseline, day 1-2, day 10, week 4, week 6, month 3, and every 3 months thereafter through 36 months. Efficacy was evaluated by mean change from 8:00 AM unmedicated baseline IOP through month 36, and the percentage of patients receiving the same or fewer topical IOP-lowering medications as at screening (pre-study). Safety was evaluated by adverse events and ophthalmic parameters. RESULTS: Clinically and statistically relevant IOP-lowering treatment effects were observed through month 36 after a single administration of the travoprost implant compared with BID timolol with mean IOP reductions ranging from 7.6 to 8.8 mmHg for the FE implant group, from 7.3 to 8.0 mmHg for the SE implant group, and from 7.3 to 7.9 for the timolol group at the 8:00 AM timepoint (P < 0.0001 for all treatment groups at all visits). At months 12, 24, and 36, a greater percentage of FE and SE implant patients versus timolol patients were well controlled on the same or fewer topical IOP-lowering medications compared with screening with 63 and 69% for the FE and SE implants groups, respectively, versus 45% for the timolol group at month 36. The safety profile of the implant was favorable; there were no dislodgements, no explantations, no adverse events of conjunctival hyperemia or periorbital fat atrophy, no discontinuations due to study eye adverse events, nor any serious adverse events in the study eye. Comparable changes from baseline in corneal endothelial cell counts were observed in the three treatment groups over the 36 months. CONCLUSION: The travoprost intraocular implant demonstrated robust IOP-lowering and substantially reduced topical IOP-lowering medication burden for up to 36 months following a single administration, while maintaining a favorable safety profile. The travoprost intraocular implant promises to be a meaningful addition to the interventional glaucoma armamentarium by addressing the key shortcomings of topical IOP-lowering medications, including low adherence and topical side effects while controlling IOP for up to 36 months. TRIAL REGISTRY: ClinicalTrials.gov identifier NCT02754596 registered 28 April 2016.

Visual and Refractive Outcomes After Bilateral Implantation of a Biconvex Aspheric Toric Monofocal Intraocular with a Double C-Loop Haptic Design.

Purpose: To show the visual and refractive outcomes in cataract patients with corneal astigmatism when bilaterally implanted with a biconvex aspheric toric monofocal intraocular lens (IOL) with a double C-loop haptic-design. Methods: Forty-seven cataract patients (94 eyes) with corneal astigmatism (≥0.75D) were implanted with the monofocal PODEYE toric IOL and assessed for 4-6 months post-surgery. Measurements included monocular and binocular uncorrected-distance visual acuity (UDVA) and corrected-distance visual acuity (CDVA), under both photopic and mesopic lighting conditions. Refraction, photopic and mesopic contrast sensitivity (with and without glare), and rotational stability were also recorded at the last postoperative visit. Results: At 4-6 months, 78.2% and 98.9% of eyes were within ±0.50D and ±1.00D of the target refraction, respectively. The mean spherical equivalent and refractive cylinder values were 0.09±0.35D and -0.36±0.35D, respectively. 76.5% and 98.8% of eyes presented a postoperative refractive cylinder of ≤0.50D and ≤1.00D, respectively. 91.5% and 100% of patients had a binocular UDVA and CDVA of ≥20/25, respectively. The mean binocular UDVA and CDVA were 0.02±0.08 and -0.02±0.07 logMAR, respectively. Under mesopic conditions, 78.7% and 83.0% of patients presented a binocular UDVA and CDVA ≥20/32, respectively. The mean binocular UDVA and CDVA were 0.15±0.11 and 0.12±0.11 logMAR, respectively. The patients showed good contrast sensitivity under photopic and mesopic conditions. The mean absolute IOL rotation was 1.22±2.21 degrees with 97.87% of eyes having a rotation of <10 degrees. Conclusion: This study shows good visual and refractive outcomes for the PODEYE toric IOL when implanted bilaterally in cataract patients with corneal astigmatism.

Prospective Randomized Single-Masked Study of Bilateral Isofocal Optic-Design or Monofocal Intraocular Lenses.

Purpose: To assess refractive and visual outcomes of bilateral implantation of an isofocal optic-design intraocular lens (IOL) or a monofocal IOL following cataract surgery. Methods: A total of 127 patients were recruited into a prospective, single-masked, randomized trial. Sixty-five patients bilaterally implanted with the Isopure Isofocal IOL and 62 patients with the Micropure Monofocal IOL were followed for 4-6 months. Refraction, monocular and binocular uncorrected-distance-visual acuity, corrected-distance-visual acuity (CDVA), uncorrected-intermediate-visual acuity and distance-corrected-intermediate-visual acuity (DCIVA, 66/80 cm), uncorrected-near-visual acuity, and distance-corrected-near-visual acuity (DCNVA, 40 cm) were evaluated. Binocular defocus curve, binocular contrast sensitivity (photopic, mesopic with/without glare), and glare and halo phenomena were also measured. Results: 99.23% of eyes were within ±1.00D and 84.62% of eyes within ±0.50D for the Isopure patients and 98.39% and 82.26% for the Micropure patients, respectively. The mean spherical-equivalent was -0.06 ± 0.36D and 0.10 ± 0.32D for the Isopure and Micropure patients, respectively. 98.5% and 100% of patients implanted with the Isopure and Micropure IOLs showed a cumulative binocular CDVA value ≥20/20, respectively. 80% and 67.70% of patients implanted with the Isopure presented a binocular DCIVA ≥20/25 at 80 and 66 cm, respectively. These percentages were 46.8% and 40.3% with the Micropure IOL, respectively. For Isopure, 7.7%, 30.8%, and 58.5% of patients presented a DCNVA ≥20/25, ≥20/32 and ≥20/40, respectively. These values were lower for the Micropure: 1.6%, 19.4% and 46.8%, respectively. Defocus curves showed similar good visual acuity at distance for both lenses with better intermediate vision for the Isopure. Both groups presented good contrast sensitivity, and the size and intensity of halo and glare phenomena were similar between the two. No adverse-events were reported. Conclusion: Our trial shows that both IOLs provide excellent visual acuity and contrast sensitivity for far vision with similar photic phenomena, and the Isopure IOL improved unaided intermediate vision performance.

Long-term trifocal toric intraocular lens outcomes in Asian eyes after cataract surgery.

PURPOSE: To determine the visual and refractive outcomes of trifocal toric intraocular lens (IOL) implantation in Asian eyes with cataract and astigmatism. SETTING: Asian Eye Institute, Makati City, Philippines. DESIGN: Prospective study. METHODS: 187 eyes were implanted with the FineVision POD FT IOL and followed for 2 years. The measurements included subjective refraction, uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected intermediate visual acuity (UIVA), distance-corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UNVA), distance-corrected near visual acuity (DCNVA), defocus curve, photopic and mesopic contrast sensitivity, and rotational stability. RESULTS: The mean spherical equivalent and cylinder values were, respectively, -0.07 ± 0.34 diopters (D) and -0.48 ± 0.31 D at the 2-year follow-up. At this same follow-up, 69.4% of patients had monocular CDVA and 79.3% had binocular UDVA ≤0.0 logMAR. For intermediate vision, monocular DCIVA reached 74.1%, while binocular UIVA was 86.2% ≤ 0.1 logMAR. Near vision showed 63% for monocular DCNVA and 70.7% for binocular UNVA ≤0.1 logMAR. The mean values at this follow-up were 0.02 ± 0.08, 0.08 ± 0.10, and 0.10 ± 0.12 logMAR for CDVA, DCIVA, and DCNVA, respectively. At the visual acuity threshold of ≤0.20 logMAR, the binocular defocus curve extended up to -3.75 D. Stable contrast sensitivity values were obtained at the different follow-ups. The mean IOL rotation was ≤2 degrees. CONCLUSIONS: The FineVision POD FT IOL yielded good visual outcomes at far, near, and intermediate distances with accurate refractive outcomes and good rotational stability in Asian eyes.

Long Term Clinical Outcomes of Hydrophilic and Hydrophobic Versions of a Trifocal IOL with the Same Optical Design.

Purpose: To show the visual and refractive outcomes in Asian eyes with cataract when bilaterally implanted with either a hydrophobic FineVision POD F GF or a hydrophilic FineVision POD F intraocular lens (IOL). Methods: Forty-six patients were randomized to receive POD F GF or POD F IOLs. Visual and refractive outcomes were assessed up to 24 months post-surgery. Measurements included uncorrected-distance visual acuity, corrected-distance visual acuity (CDVA), distance-corrected intermediate visual acuity (DCIVA), distance-corrected near visual acuity (DCNVA), refraction, defocus curve, photopic and mesopic contrast sensitivity, and patient-reported outcomes. Results: Mean spherical equivalent was close to emmetropia for both groups and stable across postoperative visits. Overall, 97.73% and 100% of eyes in the POD F GF IOL group and 95.65% and 100%, of eyes in the POD F IOL group were within ±1.00D of the target refraction at 12 and 24 months, respectively. All patients showed a CDVA of ≥20/25 at 12- and 24-months post-surgery. In both groups, 24 months post-surgery 91% of patients presented a DCIVA of ≥20/25 and 83.3% of patients had a DCNVA of ≥20/25. Defocus curve showed continuous visual acuity, being 20/32 or better in both groups over a 4.00D range between 1.00D and -3.00/-3.50D. Both groups showed good contrast sensitivity values for photopic and mesopic conditions. Overall, 86.4%, 86.4%, and 72.7% of patients implanted with the POD F GF IOL reported not wearing glasses at all for distance, intermediate, and near vision, respectively. These values were 81.8%, 86.4%, and 90.9% for patients implanted with the POD F IOL. Both groups of patients reported similar satisfaction percentages (100% very satisfied/satisfied) and would recommend the procedure (100% definitively yes/probably yes). Conclusion: This study demonstrates good visual and refractive outcomes for both the FineVision POD F GF and the FineVision POD F IOLs when implanted in Asian eyes.

Goldmann and modified Goldmann tonometry measuring intraocular pressure changes in eyes which underwent myopic laser in situ Keratomileusis and photorefractive keratectomy.

PURPOSE: Compare intraocular pressure (IOP) measured by a standard Goldmann applanation tonometer prism (IOPg) and a modified correcting applanation tonometer surface Goldmann prism (IOPc) before and after laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK). METHODS: Goldmann tonometry was analyzed in a retrospective, cross-sectional study, using both GAT and modified-GAT prisms pre-operatively and at the 3 month post-operative appointment on 120 eyes (64 patients) who received LASIK (n = 58) or PRK (n = 62). Demographics, central corneal thickness (CCT), manifest refraction and corneal curvature (CC) data was collected at each visit as well as surgical parameters, including maximum ablation depth. RESULTS: Mean paired IOP following LASIK decreased by - 3.28 ± 3.2 mmHg measured by IOPg and - 1.93 ± 3.3 mmHg by IOPc (p ≤ 0.0001). Mean paired IOP following PRK reduced by - 1.92 ± 3.6 mmHg measured by IOPg and - 1.06 ± 3.6 mmHg by IOPc (p ≤ 0.0001). Increased LASIK ablation depth and post-procedural change in CCT trended toward a statistically significant reduction in IOPg (p = 0.07,p = 0.12), but not IOPc (p = 0.18,p = 0.32). PRK ablation depth was not associated with a reduction in IOPg or IOPc. DISCUSSION: The modified Goldmann (IOPc) prism measured less of an IOP reduction following LASIK and PRK compared to the standard (IOPg) prism, and the IOP reduction with both prisms was associated with the degree of myopic correction. WHAT IS ALREADY KNOWN AND THE RESIDUAL QUERY: Corneal refractive surgery generally demonstrates significant postoperative Goldmann IOP reductions. Presumably, this is due to corneal biomechanical changes for which a newer method of Goldmann IOP measurement may be able to compensate. WHAT THIS STUDY ADDS: A modified, corneal conforming Goldmann prism demonstrates significantly less IOP reduction following myopic LASIK and PRK compared to the standard flat Goldmann prism. HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY: A newer, modified Goldmann prism may help detect glaucoma and OHT at an earlier stage in patients which have undergone LASIK or PRK. The findings corroborate predicted corneal biomechanical changes following the most common corneal refractive procedures.

Review of surgical devices using small aperture optics.

Small aperture optics work by blocking unfocused peripheral light rays while allowing central light rays to focus on the retina. This pinhole effect creates an extended depth of focus and has been used in presbyopia correction, improving intermediate and near vision without markedly affecting distance vision. Another beneficial effect of small aperture optics is reducing aberrations caused by irregular corneas or irregular pupils. The first small aperture surgical device was the Kamra corneal inlay used on the nondominant eyes of presbyopic emmetropes. The pinhole concept was also adapted into the IC-8 intraocular lens (IOL) for presbyopia correction during cataract surgery and by the XtraFocus piggyback device to lessen unwanted aberrations in eyes with irregular corneas or pupils. The IC-8 IOL can be placed monocularly or binocularly with mini-monovision for further near vision improvement. The XtraFocus piggyback device can be placed either in the sulcus or capsular bag. The aim of this literature review is to synthesize evidence on the efficacy, safety, and patient-reported outcomes on surgical devices utilizing small aperture optics. A comprehensive search on PubMed was conducted with the keywords "small aperture optics," "small aperture corneal inlay," "small aperture IOL," "Kamra corneal inlay," "IC-8 IOL," and "XtraFocus." In this review, we describe the progression of small aperture surgical devices, patient criteria, visual outcomes, complications, satisfaction, and recommendations for surgical success.

Clinical outcomes and comparison of intraocular lens calculation formulas in eyes with long axial myopia.

PURPOSE: The purpose of this study was to report the clinical and refractive outcomes of eyes with long axial length (AL) and high myopia that underwent cataract surgery and compare the performance of intraocular lens (IOL) calculation formulae on these eyes. MATERIALS AND METHODS: This retrospective cohort included 183 eyes that underwent cataract surgery from January 2010 to December 2018. Demographics, AL, postoperative best-visual acuities, IOL power data, and postoperative complications were recorded. Refractive outcomes were analyzed and absolute predicted errors were compared between five IOL calculation formulas. RESULTS: The mean age included in the study was 65.4 ± 9.39 years with a mean AL of 26.76 ± 1.75 mm. Postoperatively, the mean sphere, cylinder, and manifest refraction spherical equivalent were 0.22 D ± 0.54, -0.78 D ± 0.50, and - 0.16 D ± 0.50, respectively. The average IOL power implanted was 11.12 D ± 4.59 D. No intraoperative complications were encountered, but there was one incidence of retinal tear with detachment reported postoperatively (0.55%). The Kane formula had the lowest mean absolute predicted error (MAE). A significant positive correlation between increasing AL and MAE was seen in the Sanders, Retzlaff and Kraft-Theoretical (SRK-T) and Ladas formulae but not statistically significant when the Kane, Barrett Universal II, and the Emmetropia Verifying Optical (EVO) formulae were used. CONCLUSION: Cataract surgery in eyes with long ALs and high myopia is safe with a low incidence of intraoperative and postoperative complications. The Kane, Barrett, and EVO formulae were equally accurate in calculating the IOL power and achieved the least amount of residual error postoperatively.

Comparison of white-to-white measurements using four devices and their determination of ICL sizing.

BACKGROUND: To compare the measurements obtained from the Orbscan II, IOLMaster 700, Pentacam AXL, and Castroviejo caliper and their effects on calculating the recommended implantable collamer lens (ICL) size and postoperative vault measurements. METHODS: This is a retrospective cross-sectional study of patients who underwent ICL surgery by a single surgeon from March 1, 2018 to July 31, 2021. Records were reviewed for the anterior chamber depth (ACD) and white-to-white (WTW) measurements obtained from the Orbscan II, IOLMaster 700, Pentacam AXL, and Castroviejo caliper (WTW only). These were used to calculate the recommended ICL size. The actual ICL size implanted, and vault measurements obtained one month postoperatively were also collected. RESULTS: One hundred seven eyes with a mean age of 27.9 ± 7.7 years were included in the study. Mean WTW measurements were significantly different between devices (P < 0.0001), with the IOLMaster 700 having the highest value (12.14 ± 0.04 mm) and the caliper having the lowest value (11.45 ± 0.04 mm). Mean ACD measurements were the lowest in Orbscan II (3.12 ± 0.25 mm) and the highest in Pentacam AXL (3.16 ± 0.24 mm). The Pentacam AXL produced an ICL size similar to the Orbscan in 69.2% of eyes. The IOLMaster yielded an ICL measurement one size larger than Orbscan-based calculations in 64.5% of eyes. Using the Orbscan WTW and ACD, the desired vault of 0.25 to 0.75 mm and 0.25 to 1.00 mm was achieved in 70% and 91% of eyes, respectively. Substituting caliper WTW to IOLMaster 700 or Pentacam AXL WTW increases the percentage of achieving the desired vault to 80%, similar to the Orbscan. CONCLUSIONS: The Orbscan II, IOLMaster 700, and Pentacam AXL cannot be used interchangeably for calculating ICL sizing. Combining the WTW from caliper measurement with the ACD of the IOLMaster 700 or Pentacam AXL could improve ICL sizing and achieve a higher percentage of eyes with the desired vault.

Comparison of Three Tonometers in Measuring Intraocular Pressure in Eyes That Underwent Myopic Laser in situ Keratomileusis and Photorefractive Keratectomy.

Objective: To compare the intraocular pressure (IOP) obtained by Goldmann applanation tonometer (GAT), correcting applanation tonometer surface (CATS) and biomechanically corrected IOP (bIOP) of Corvis ST tonometer (CVS); and to determine the effects of manifest refraction spherical equivalent (MRSE), central corneal thickness (CCT) and mean corneal curvature (Km) on the IOP measurements of corneal refractive patients. Methods: This was a single-center, retrospective, cross-sectional study of 120 eyes of 64 patients from May 1, 2020 to June 1, 2021 who underwent laser in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK). The level of agreement between the three tonometers was evaluated, and correlation between parameters was calculated using Pearson correlation. Results: Mean preoperative to postoperative IOP in LASIK and PRK was 15.1 ± 3 to 11.3 ± 2.1 and 14.4 ± 2.6 to 12.1 ± 3 using GAT, 16.4 ± 2.8 to 13.1 ± 2.3 and 15.9 ± 2.6 to 13.7 ± 3 using CATS and 14.8 ± 2.4 to 12.9 ± 1.5 and 14.2 ± 2.4 to 12.6 ± 1.9 using CVS-bIOP. Preoperative IOP correlation between each tonometer pair showed that the lowest mean difference was between GAT and CVS-bIOP (0.32 in LASIK, 0.15 in PRK). Preoperative to postoperative IOP correlation of each tonometer resulted in a difference of 3.77, 2.30 in GAT; 3.32, 2.28 in CATS and 1.88, 1.62 in CVS-bIOP in the LASIK and PRK groups, respectively. Percentage change in CCT and Km was not correlated while change in MRSE had a weak relationship with percentage change in CVS-bIOP. Conclusion: Preoperatively, GAT and CVS-bIOP had the best agreement in IOP measurements. CATS recorded the highest IOP preoperatively and postoperatively. IOP decreased in the three tonometers after LASIK and PRK with GAT having the largest decrease. CVS-bIOP had the lowest change between preoperative and postoperative IOP measurements. Only percentage change in MRSE was correlated with percentage change in CVS-bIOP in the LASIK group.

Comparison of 3-month visual outcomes of a new multifocal intraocular lens vs a trifocal intraocular lens.

PURPOSE: To compare the clinical performance of the TECNIS Synergy multifocal (model ZFR00V) intraocular lens (IOL) with that of the AcrySof PanOptix Trifocal (model TFNT00) IOL in patients undergoing bilateral cataract surgery. SETTING: Multicenter clinical setting. DESIGN: Prospective randomized comparative study. METHODS: Patients aged 22 years or older were randomly assigned (2:1) to bilateral implantation with ZFR00V or TFNT00 IOLs. End points included the mean binocular distance-corrected near visual acuity (DCNVA) at 40 cm, photopic and mesopic DCNVAs at 33 cm, photopic low-contrast corrected distance visual acuity (CDVA) and mesopic CDVA, nondirected patient responses to an ocular/visual symptoms questionnaire, and safety. RESULTS: Of the 150 patients implanted with IOLs, 95 of the 97 patients with ZFR00V IOLs and 52 of the 53 patients with TFNT00 IOLs completed the 3-month follow-up. Most patients in the ZFR00V and TFNT00 groups achieved 20/25 or better binocular CDVA (100% vs 96.2%) and DCNVA measured at 40 cm (88.4% vs 75.0%) and 33 cm (78.9% vs 51.9%). The mean between-group difference in binocular DCNVA at 40 cm favored ZFR00V IOLs (0.5 lines Snellen; 95% CI, 0.012 to 0.089; P ≤ .05). Similarly, the mean binocular photopic and mesopic DCNVAs at 33 cm (0.8 lines Snellen each; both P ≤ .05 vs TFNT00) and photopic high-contrast and low-contrast CDVA (0.5 lines Snellen each; both P ≤ .05 vs TFNT00) favored ZFR00V IOLs. Patient-reported ocular/visual symptoms and safety were generally similar between the 2 IOLs. CONCLUSIONS: The ZFR00V IOL showed an extensive range of vision, particularly through near distances, and better mesopic performance than the TFNT00 IOL in patients undergoing cataract surgery.

Visual outcomes after optic exchange of a modular intraocular lens.

PURPOSE: To evaluate the effectiveness of the Harmoni Modular IOL (HMIOL). SETTING: 3 study sites. DESIGN: Prospective, multicenter clinical study. METHODS: HMIOL is a foldable, posterior chamber lens with separate base and exchangeable optic components. Eligible adults undergoing cataract surgery received HMIOL in the study eye (monovision target -1.50 diopters [D]) and standard monofocal IOL in contralateral eye (control). After 3 months, subjects could undergo optic exchange based on visual outcomes. End points included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and manifest refractive spherical equivalent (MRSE). Follow-up was 12 months or greater postoperatively. RESULTS: 114 subjects had successful HMIOL implantation in study eye and control IOL in contralateral eye. At 3 months, subjects could undergo optic exchange if unsatisfied with monovision; 65 eyes had optic exchange (exchange cohort), and 49 eyes had no exchange (no exchange cohort). In exchange cohort, the proportion of eyes with UDVA of 20/40 or greater and of 20/20 or greater increased 3 months after optic exchange vs preexchange levels by 23% (97% vs 74%) and 40% (49% vs 9%), respectively. In all cohorts, 95% of subjects or greater achieved UDVA of 20/40 or greater after 12 months or greater. Control and no exchange cohorts achieved CDVA of 20/40 or greater by 3 months; 97% of eyes or greater had CDVA of 20/40 or greater at 12 months after optic exchange. In exchange cohort, the proportion of eyes with MRSE within ±0.50 D and ±1.00 D of target changed by 57% and 36%, respectively, from preexchange (20% and 59%, respectively) to 12 months postexchange (77% and 95%, respectively), reaching levels similar to control subjects (72% and 97%, respectively). CONCLUSIONS: HMIOL provided visual outcomes comparable with standard monofocal IOLs.

Evaluation of Intraocular Lens Rotational Stability in a Multicenter Clinical Trial.

PURPOSE: To evaluate the postoperative rotational stability of two prototype intraocular lens (IOL) designs (subsequently termed version 1 and version 2). PATIENTS AND METHODS: A prospective, multicenter, randomized, paired-eye, 6-month study evaluated the version 1 and version 2 IOLs. Results were compared with a control IOL (TECNIS® toric 1-piece monofocal IOL) evaluated in a separate, similarly designed study. Participants aged ≥22 years and scheduled to undergo bilateral cataract extraction were randomly assigned 1:1 to receive the version 1 or version 2 IOL in the first operative eye; the alternate test IOL was then implanted in the second operative eye. RESULTS: Mean absolute IOL rotation at postoperative week 1 was the primary effectiveness end point. Additional end points included the percentage of eyes with postoperative IOL rotation >5°/>10°, direction of lens rotation, surgeon-reported ease of IOL handling during implantation, and safety. At postoperative week 1, mean (±standard deviation) absolute IOL rotation was significantly lower for both version 1 and version 2 versus control (0.88° [±0.94] and 0.71° [±0.69] vs 2.24° [±3.21], respectively; both P < 0.001). For both study lenses, absolute rotation was <5° for all eyes at postoperative week 1, and no cases of rotation >10° were observed at any postoperative time point. From postoperative week 1 onward, version 2 had a statistically significant clockwise bias in the direction of rotation (P = 0.03); similar findings were observed for version 1. Surgeons reported acceptable ease of IOL handling during implantation for both version 1 and version 2. No device-related adverse events were reported. CONCLUSION: Both the version 1 and version 2 IOLs, each with frosted, squared haptics, demonstrated improved postoperative rotational stability compared with a control lens without frosted haptics. Because version 2 had the same overall geometry as the current TECNIS toric IOL, this design was selected for commercialization. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00015287.

Evaluation of safety after optic exchange of a modular intraocular lens.

PURPOSE: To characterize safety of optic exchange using a modular lens. SETTING: 3 study sites, New Zealand, Philippines. DESIGN: Prospective clinical study. METHODS: Harmoni Modular intraocular lens (HMIOL) with separate base and optic components was implanted in the study eye (monovision target -1.50 diopter). Contralateral eyes received standard monofocal IOLs. Subjects could elect optic exchange 3 months after primary implantation. Adverse events (AEs) and endothelial cell loss (ECL) were assessed through 12 months of follow-up. RESULTS: 114 subjects successfully received HMIOL and 114 received control lens in contralateral eye. At 3 months, 65 HMIOL eyes had optic exchange because of unsatisfactory visual outcome from high monovision (exchange cohort); 49 eyes received no exchange (no exchange cohort). Exchange, no exchange, and control cohorts reported ocular AEs in 10 (15%), 6 (12%), and 14 (12%) eyes, respectively. No posterior capsular rupture occurred during optic exchange procedures. Short-term (12-month) posterior capsule opacification (PCO) evaluation showed that all eyes had PCO grade 1 or less at 12 months; no Nd:YAG capsulotomy was performed in the exchange cohort. No exchange and exchange cohorts had similar ECL at 3 months vs preoperative baseline (-4.5%, n = 48 and -4.0%, n = 65). In the exchange cohort, additional 2.7% ECL occurred 3 months after optic exchange compared with preexchange baseline; ECL was significantly below the 14% threshold (P < .001) and was 5.8% at 12 months. CONCLUSIONS: HMIOL safety outcomes were comparable with standard monofocal IOLs; HMIOL may provide an effective method for correcting postoperative refractive errors.

A Comparative Evaluation of Visual, Refractive, and Patient-Reported Outcomes of Three Extended Depth of Focus (EDOF) Intraocular Lenses.

OBJECTIVE: To compare visual, refractive, and patient-reported outcomes of patients implanted with one of three types of extended depth of focus (EDOF) intraocular lenses. SETTING: Asian Eye Institute, Philippines. DESIGN: Retrospective cohort study. METHODS: Subjects implanted with Symfony (Johnson and Johnson, USA), IC-8 (AcuFocus, USA), and WIOL (Medicem, Czech Republic) EDOF intraocular lenses were recruited. Spherical equivalent, uncorrected and corrected visual acuity, defocus curve, and modulation-transfer function, Strehl ratio, and visual Strehl optical transfer function values, photic phenomena, and questionnaire answers were measured and assessed. RESULTS: A total of 32 eyes with the Symfony lens, 30 with the IC-8 lens, and 32 with the WIOL lens were included in the study. Mean postoperative spherical equivalent was -0.24 D for the Symfony, -0.17 D for the IC-8, and 0.27 D for WIOL. There were no significant differences in postoperative monocular and binocular uncorrected and corrected visual acuity. On a monocular defocus curve, the IC-8 and Symfony showed significantly better vision than WIOL. The Symfony had significantly better modulation-transfer function, Strehl ratio, and visual Strehl optical transfer function. No difference was seen among the three lenses with regard to glare or starburst, while patient satisfaction remained high in all groups for far, intermediate, and near vision. CONCLUSION: All eyes implanted with the three EDOF designs achieved excellent far and intermediate vision, with acceptable near vision. The IC-8 and Symfony exhibited a better range of vision on defocus-curve testing. The Symfony showed superior results in quality of vision. Patient satisfaction was high in all three EDOF groups.

Visual Performance of a Small-Aperture Intraocular Lens: First Comparison of Results After Contralateral and Bilateral Implantation.

PURPOSE: To evaluate visual performance in patients implanted contralaterally and bilaterally with the small-aperture hydrophobic acrylic intraocular lens (IOL) (IC-8 IOL; AcuFocus, Irvine, CA). METHODS: In this prospective, non-randomized, non-comparative study, 10 contralateral patients were implanted with a monofocal IOL in one eye and an IC-8 IOL in the other. There were 10 bilateral patients implanted with an IC-8 IOL in both eyes. All patients were observed for at least 12 months after the study device was implanted in each eye. Visual acuity, patient satisfaction, ease of task performance, visual symptoms, defocus curves, and contrast sensitivity comparisons are presented. RESULTS: For bilateral and contralateral patients, the mean uncorrected and corrected distance binocular acuities were 20/25 or better at all distances. All 10 (100%) contralateral and 10 (100%) bilateral patients achieved 20/32 or better binocular uncorrected and corrected distance visual acuity at all distances. The improvement in binocular uncorrected intermediate and uncorrected near visual acuity was 0.5 to 1 line greater in bilateral patients. Bilateral implantation extended the depth focus range by 0.25 diopters. The mean log contrast sensitivity was similar in both groups for mesopic without glare and with glare conditions at all spatial frequencies (P > .05). Bilateral patients had better overall satisfaction, satisfaction with near tasks, and spectacle independence and they rated many near tasks as easier to perform. CONCLUSIONS: Results demonstrate that both contralateral and bilateral implantation of an IC-8 IOL provide excellent visual acuity across all distances. Bilateral implantation can be successful based on careful patient selection and optimization of refractive targets. [J Refract Surg. 2020;36(1):12-19.].

A Prospective Randomized Trial Comparing Hydrus and iStent Microinvasive Glaucoma Surgery Implants for Standalone Treatment of Open-Angle Glaucoma: The COMPARE Study.

PURPOSE: To compare the efficacy of different microinvasive glaucoma surgery (MIGS) devices for reducing intraocular pressure (IOP) and medications in open-angle glaucoma (OAG). DESIGN: Prospective, multicenter, randomized clinical trial. PARTICIPANTS: One hundred fifty-two eyes from 152 patients aged 45 to 84 years with OAG, Shaffer angle grade III-IV, best-corrected visual acuity (BCVA) 20/30 or better, and IOP 23 to 39 mmHg after washout of all hypotensive medications. Eyes with secondary glaucoma other than pseudoexfoliative or pigmentary glaucoma, angle closure, previous incisional glaucoma surgery, or any significant ocular pathology other than glaucoma were excluded. INTERVENTION: Study eyes were randomized 1:1 to standalone MIGS consisting of either 1 Hydrus Microstent (Ivantis, Inc, Irvine, CA) or 2 iStent Trabecular Micro Bypass devices (Glaukos Inc, San Clemente, CA). Follow-up was performed 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively. MAIN OUTCOME MEASURES: Within-group and between-group differences in IOP and medications at 12 months and complete surgical success defined as freedom from repeat glaucoma surgery, IOP 18 mmHg or less, and no glaucoma medications. Safety measures included the frequency of surgical complications, changes in visual acuity, slit-lamp findings, and adverse events. RESULTS: Study groups were well matched for baseline demographics, glaucoma status, medication use, and baseline IOP. Twelve-month follow-up was completed in 148 of 152 randomized subjects (97.3%). At 12 months, the Hydrus had a greater rate of complete surgical success (P < 0.001) and reduced medication use (difference = -0.6 medications, P = 0.004). More Hydrus subjects were medication free at 12 months (difference = 22.6% P = 0.0057). Secondary glaucoma surgery was performed in 2 eyes in the 2-iStent group (3.9%) and in none of the Hydrus eyes. Two eyes in the Hydrus group and 1 in the 2-iStent group had BCVA loss of ≥2 lines. CONCLUSION: Standalone MIGS in OAG with the Hydrus resulted in a higher surgical success rate and fewer medications compared with the 2-iStent procedure. The 2 MIGS devices have similar safety profiles.

Comparison of tolerance to induced astigmatism in pseudophakic eyes implanted with small aperture, trifocal, or monofocal intraocular lenses.

Purpose: To compare the effect of induced astigmatic defocus on visual performance in pseudophakic eyes implanted with a small aperture, trifocal, or monofocal intraocular lens (IOL). Patients and methods: The study included 44 eyes with one of four types of IOL (IC-8 IOL (AcuFocus Inc., USA); FineVision (PhysIOL SA, Belgium); AT Lisa (Carl Zeiss AG, Germany); and enVista monofocal (Bausch & Lomb, USA). For astigmatic tolerance assessment, monocular distance visual acuity was measured with cylindrical lenses (power range=0.00-2.50 diopters (D) in 0.50 D increments) added to the subjects best-corrected distance manifest refraction. The assessment was repeated on three pre-determined axes (90°, 180°, and either 45° or 135°). The magnitude of astigmatic tolerance at each defocus step was assessed by taking the difference between logMAR visual acuity at the defocus step relative to that at 0.0 D (ie, no defocus condition). Results: Across all three axes, the reduction of mean monocular visual acuity at all defocus levels relative to no defocus was significantly smaller in IC-8 group compared to the other IOL groups. When the data was combined across all axes, the astigmatic tolerance of the IC-8 group was better than AT Lisa group from 0.50 D to 2.50 D and FineVision group from 0.50 D to 1.50 D (all P<0.05, ANOVA). The IC-8 group was better than the enVista group, but not significantly (P>0.05, ANOVA). Among individual orientations, statistically significant differences were seen between IC-8 IOLs and the other IOLs, with the largest difference being in the oblique axis. Astigmatic tolerance at all axes combined was 1.40 D for IC-8 IOL, 0.70 D for AT Lisa and FineVision, and 1.00 D for enVista IOLs. Conclusion: The small aperture IC-8 IOL showed greater tolerance to induced astigmatic defocus compared to trifocal and monofocal IOLs.