Clinical outcomes of the light adjustable lens in eyes with a history of prior corneal refractive surgery.

PURPOSE: This study aimed to evaluate the visual and refractive outcomes in eyes with a history of laser corneal refractive surgery implanted with the second-generation light-adjustable lens (LAL). SETTING: Private Practice, Sioux Falls, South Dakota, US. DESIGN: Retrospective, consecutive case series. METHODS: Eyes with a history of prior corneal refractive surgery that underwent cataract surgery with implantation of the LAL and were targeted for plano were included. Data on the type and number of prior refractive surgeries were collected, in addition to the timing and number of postoperative adjustments. The primary outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and the percentage (%) of eyes within ±0.25 diopter (D), ±0.50D, and ±1.00 D of their refractive target. RESULTS: 76 eyes from 70 patients were included. A total of 45 eyes with a history of one prior refractive surgery and 31 eyes with a history of ≥2 refractive surgeries were included. 74% (n=56) of all eyes achieved UDVA of 20/20 or better, 88% (n=67) achieved 20/25 UDVA or better and 93% (n=71) were correctable to 20/20 or better postoperatively. For refractive outcomes, 66% of eyes (n=50) were within ±0.25 D and 86% (n=65) were within ±0.50 D of refractive target. CONCLUSIONS: Patients with a history of laser corneal refractive surgery achieved favorable visual and refractive outcomes with the LAL. This intraocular lens (IOL), which affords postoperative adjustability, is a promising option for patients with a history of corneal refractive surgery who maintain high expectations for functional uncorrected acuity following cataract surgery.

Clinical Outcomes of a Non-Diffractive Extended Depth-of-Focus IOL in Eyes with Mild Glaucoma.

Purpose: To evaluate the clinical outcomes of a non-diffractive, wavefront-shaping extended depth-of-focus (EDOF) intraocular lens (IOL) in eyes with mild open-angle glaucoma (OAG). Setting: Private practice; Sioux Falls, South Dakota. Design: Prospective, open-label, interventional study. Methods: In total, 52 eyes of 26 patients with mild OAG were enrolled and completed the study. All patients were bilaterally implanted with a non-diffractive, wavefront-shaping EDOF IOL. Seventy-seven percent of the patients were implanted with a trabecular microbypass stent at the time of surgery. Primary outcome measures included binocular corrected and uncorrected distance visual acuity (CDVA and UDVA), uncorrected intermediate and near visual acuity (UIVA and UNVA) and contrast sensitivity as measured by a Pelli-Robson chart. A subjective questionnaire was also administered to patients. Results: At 4 months postoperative, the mean binocular UDVA and CDVA was 0.03 ± 0.12 and -0.06 ± 0.07, respectively. The mean UIVA and UNVA were 0.18 ± 0.12 and 0.31 ± 0.18, respectively. Eighty-five percent of the subjects achieved ≥20/25 UDVA and 77% of the subjects achieved ≥20/32 UIVA at 4 months postoperative. The mean binocular mesopic contrast sensitivity was 1.76 ± 0.16 at a spatial frequency of 1 cycle-per-degree (cpd). Eighty-five percent of the subjects reported they would choose the same lens and 1 subject reported they would choose a different IOL if it meant reduced spectacle independence. Conclusion: The non-diffractive, wavefront-shaping EDOF IOL can be safely implanted in eyes with mild, pre-perimetric open-angle glaucoma with favorable uncorrected distance and intermediate visual acuity. The contrast sensitivity measurements were favorable and the subjective questionnaire revealed satisfactory spectacle independence and patient satisfaction.

Canaloplasty and trabeculotomy with the OMNI® surgical system in OAG with prior trabecular microbypass stenting.

PURPOSE: Evaluate effectiveness and safety outcomes for patients treated with canaloplasty and trabeculotomy previously treated with a trabecular microbypass stent (TBS). METHODS: Retrospective, multicenter, IRB approved study. Patients treated with TBS (iStent/iStent inject, Glaukos) and subsequently with OMNI surgical system (OSS) (Sight Sciences). From 5 practices in 5 US states. Open-angle glaucoma (OAG), minimum 3 months follow-up after OSS surgery, Pre-OSS IOP ≥ 17 mmHg on ≥ 1 medication. No glaucoma procedures between TBS and OSS. ENDPOINTS: proportion with ≥ 20% reduction in IOP, IOP between 6 and 18 mmHg, mean IOP, change in IOP, mean number of medications. Adverse events and secondary surgical interventions (SSI). Mann-Whitney rank sum test compared pre-OSS IOP and medications with follow-up. RESULTS: Twenty seven patients. Average age (SD) 72.2 (10.8), 22/27 primary OAG (82%), mean MD - 6.2 (7.0) dB. Mean IOP before OSS 22.3 (4.3) mmHg on 2.2 (1.3) medications. At last follow-up (mean 11 months) IOP was 17.2 mmHg on 1.8 medications, - 5.1 mmHg (- 23%, p < .001), - 0.4 meds (- 18%, p = .193); ≥ 20% IOP reduction (41%), IOP ≤ 18 (56%). Adverse events were non-serious. Hyphema > 1 mm (3, 11%), BCVA decrease (4, 15%), IOP spike (2, 7%). SSI (4, 15%) had higher pre-OSS IOP (23.4 mmHg) and worse MD (- 9.6 dB). CONCLUSION: Patients uncontrolled by medication and a prior TBS would once have been candidates for trabeculectomy and tube shunts. OSS offered a minimally invasive option that provided IOP control and avoidance of traditional surgery for the majority over follow-up averaging 11 months and up to 42 months.

A Multicenter 12-Month Retrospective Evaluation of Canaloplasty and Trabeculotomy in Patients with Open-Angle Glaucoma: The ROMEO 2 Study.

Purpose: Twelve-month safety and effectiveness results for canaloplasty combined with trabeculotomy using the OMNI surgical system in pseudophakic eyes or combined with cataract surgery in mild-to-moderate open-angle glaucoma (OAG). Setting: Sixteen centers in 11 US states (AL, AR, CA, CT, KS, LA, MO, NY, SD, TN, TX). Design: Retrospective, case series, open-label. Methods: A total of 136 eligible patients from 20 surgeons: mild-to-moderate OAG (visual field mean deviation (MD) not worse than -12 dB), 12-month follow-up, preoperative medicated IOP >18 mmHg and ≤36 mmHg on ≤5 medications. One eye per patient enrolled. Endpoints included proportion with ≥20% reduction in IOP or IOP between 6 and 18 mmHg (inclusive) and on the same or fewer medications without secondary surgical intervention (SSI) (primary success), mean IOP, change in IOP, ocular hypotensive medication use, and proportion of patients with a 20% or greater reduction in IOP at 12 months. Safety: adverse events (AE) and best corrected visual acuity (BCVA). Results: Primary success was met by 71%. Mean IOP was reduced (22.3-15.9 mmHg, p < 0.0001). Medications went from 1.9 ± 1.3 to 1.3 ± 1.2 (p < 0.001). AE were mild and as expected for angle surgery. The most frequent AE were BCVA loss (6%), mild inflammation (4%), IOP elevation (3%), and clinically significant hyphema (3%). There were 4 (3%) SSI. Conclusion: The OMNI system provides effective IOP reduction, sustained IOP control, and meaningful medication reduction for up to 12 months postoperative. The present study confirms and extends the results from ROMEO.

Short-Term Efficacy of Combined ab Interno Canaloplasty and Trabeculotomy in Pseudophakic Eyes with Open-Angle Glaucoma.

Purpose: To evaluate short-term outcomes of combined ab interno canaloplasty and trabeculotomy in pseudophakic eyes with open-angle glaucoma. Patients and Methods: Series included all pseudophakic eyes with open-angle glaucoma treated with up to 360° ab interno canaloplasty and up to 360° ab interno trabeculotomy using a purpose-engineered device (OMNI, Sight Sciences Inc). Data collected prior to surgery and out to 6-months postoperative. Surgical success defined as a 20% reduction in intraocular pressure (IOP) without increase in glaucoma medication, or discontinuation of at least one glaucoma medication without increase in IOP. Other primary endpoints included mean IOP and number of glaucoma medications. Results: The study included 67 eyes of 52 patients with a mean age of 76.5 ± 8.9 years. Preoperative mean IOP was 22.1±8.0 mmHg on 2.3±1.4 glaucoma medications. Pressure lowering effects were sustained out to 6 months postoperative with a mean IOP of 15.2±4.9 mmHg (p < 0.001) and mean medication reduction of 0.7±1.4 (p < 0.001). Surgical success rate was 69.8% (30 eyes) and correlated with preoperative IOP. Two patients required a secondary surgical intervention. Conclusion: Combined ab interno canaloplasty and trabeculotomy as a standalone procedure is an effective means of reducing IOP and medication burden in pseudophakic eyes with open-angle glaucoma.

Descemet Membrane Endothelial Keratoplasty and light adjustable lens triple procedure.

PURPOSE: The objective of this series is to report the early post-operative visual outcomes of a novel triple procedure utilizing Descemet membrane endothelial keratoplasty (DMEK) plus light adjustable lens (LAL) in two patients (four eyes). METHODS: Two patients with bilateral, visually significant cataracts and Fuchs' dystrophy were selected for DMEK plus LAL triple procedure. Patient B also exhibited a high amount of preoperative astigmatism. Both patients desired spectacle independence and were initially targeted for monovision with the dominant eye corrected for distance and the nondominant eye corrected for near. Best corrected visual acuity (BCVA), uncorrected visual acuity (UCVA), and manifest refraction were recorded at each postoperative appointment and light treatment. RESULTS: In the early post-operative course, Patient A chose to pursue binocular distance correction instead of monovision. This was adjusted for accordingly using the LAL. Following final lock-in, Patient A had a distance UCVA of 20/15 in the right eye (OD) and a distance UCVA of 20/20 in the left eye (OS). Patient B was targeted for monovision. After final lock-in, Patient B had a distance UCVA of 20/15 in the dominant eye (OD) and a near UCVA of Jaeger No. 1+ in the nondominant eye (OS). CONCLUSIONS AND IMPORTANCE: The first reported cases of DMEK plus LAL triple procedures achieved exceptional UCVA at the desired target. The post-operative customizability of the LAL allows for the achievement of excellent refractive outcomes after DMEK, even in patients with significant astigmatism and in patients who change their mind regarding refractive target.

Accuracy of partial coherence interferometry in patients with large inter-eye axial length difference.

BACKGROUND: To determine accuracy of partial coherence interferometry (PCI) in patients with large inter-eye axial eye length (AEL) difference. METHODS: Patients undergoing cataract surgery at two academic medical centers with an inter-eye axial eye length (AEL) difference of > 0.30 mm were identified and were matched to control patients without inter-eye AEL difference > 0.30 mm on the basis of age, sex, and AEL. The expected post-operative refraction for the implanted IOL was calculated using SRK/T, Holladay II, and Hoffer Q formulae. The main outcome measures were the refractive prediction error and the equivalence of the refractive outcomes between the subjects and controls. RESULTS: Review of 2212 eyes from 1617 patients found 131 eyes of 93 patients which met inclusion criteria. These were matched to 131 control eyes of 115 patients. The mean AEL was 24.92 ± 1.50 mm. The mean absolute error (MAE) ranged from 0.47 D to 0.69 D, and was not statistically different between subjects and controls. The refractive prediction error was equivalent between the cases and controls, with no significant difference between the MAE for any formula, nor in the number of cases vs. controls with a refractive prediction error of at least 0.50 D or 1.00 D. CONCLUSIONS: Among eyes in our study population, good-quality PCI data was equally accurate in patients with or without an inter-eye AEL difference > 0.30 mm. Confirmatory AEL measurements using different AEL measuring modalities in patients with a large inter-eye AEL difference may not be necessary.

DMEK outcomes using nondiabetic grafts for recipients with diabetes mellitus.

PURPOSE: To compare Descemet membrane endothelial keratoplasty (DMEK) outcomes using nondiabetic grafts in diabetic and nondiabetic recipients. METHODS: All eyes that underwent DMEK between February 2013 and October 2016 (follow-up ≥3 months, without prior keratoplasty) were included. Recipients were divided into diabetic (insulin dependent [IDDM] or noninsulin dependent [NIDDM]) and nondiabetic groups. Main outcome measures included postoperative visual acuity, rebubble procedure rates, and graft failure rates. RESULTS: Of 334 eyes (243 subjects) included for analysis, 63 eyes (18.8%) were from diabetic recipients. At each timepoint, best-corrected visual acuity trended lower for IDDM recipients compared to NIDDM and nondiabetic recipients. There were no statistically significant differences in rebubble rates of diabetic compared to nondiabetic recipients (20.6% vs. 12.9%, p = 0.17), or IDDM compared to nondiabetic recipients (27.3% vs. 12.9%, p = 0.08; hazard ratio 2.26). Overall, 13 grafts (3.9%) failed (mean follow-up, 565 days; range, 90-1293 days). Graft failures did not differ between diabetic and nondiabetic recipients (4.0% vs. 4.9%, p = 0.15) regardless of subgroup (p = 0.36). CONCLUSIONS: DMEK provides excellent outcomes for patients with and without diabetes. DMEK outcomes were excellent with improvements in visual acuity and low rates of graft failure. Our findings were unable to determine differences between rebubble procedure rates but do emphasize the need for further research using stratified groups based on diabetes severity.

Small-incision 4-point scleral suture fixation of a foldable hydrophilic acrylic intraocular lens in the absence of capsule support.

PURPOSE: To determine the visual outcomes and complications of a new small-incision technique for 4-point fixation of a hydrophilic acrylic posterior chamber intraocular lens (IOL) in the absence of capsule support. SETTING: Three North American tertiary referral centers and a private practice. DESIGN: Retrospective case series. METHODS: Secondary IOL placement was performed from 2011 to 2014. Indications for surgery, clinical results, and complications were analyzed. Primary outcomes included postoperative corrected distance visual acuity (CDVA) and surgical complications. RESULTS: Charts of 35 patients (37 eyes) were reviewed. The mean age at surgery was 56 years, and the mean follow-up was 6 months (range 3 to 24 months). Clinical indications included a dislocated IOL (30%), ocular trauma (19%), crystalline lens subluxation (19%), uveitis-glaucoma-hyphema syndrome (5%), post-complicated cataract (8%), congenital cataract (8%), and decompensated cornea (3%). The mean CDVA improved from 20/80 preoperatively to 20/40 postoperatively (P < .01). Thirty-six eyes (97%) had an improved or unchanged CDVA, and 1 eye (3%) had a reduced CDVA because of worsening glaucoma. Postoperative complications included ocular hypertension (24%), iritis (5%), wound leakage (3%), transient corneal edema (3%), glaucoma requiring a tube shunt (3%), and IOL dislocation (3%). CONCLUSION: Small-incision 4-point scleral fixation of the Akreos AO60 hydrophilic acrylic IOL in the absence of capsule support appears to be a safe and effective technique for secondary IOL placement. FINANCIAL DISCLOSURES: Drs. Berdahl and Ayres are consultants to Bausch & Lomb, Inc. Drs. Ayres and Fram have received speaker fees from Bausch & Lomb. Dr. Terveen does not have a financial or proprietary interest in any material or methods mentioned.

Results of a pediatric vision screening program in western South Dakota.

BACKGROUND: South Dakota is one of eight states that do not require any vision screening for children. This study describes the results of the first children's vision screening program in the state. METHODS: Children ages 6 months to 12 years were screened using the SPOT photoscreener by lay volunteers as part of the Northern Plains Eye Foundation's Western South Dakota Children's Vision Screening Initiative (CVSI). Referral criteria were based on the recommendations of the manufacturer. Data was stratified by age group, sex, and percentage of children referred for hyperopia, myopia, astigmatism, anisocoria, anisometropia, and ocular misalignment. The cost benefit of amblyopia treatment in South Dakota was also calculated. RESULTS: Screenings were completed on 4,784 children from August 2012 to May 2014 with 62 excluded due to age. Mean age of the 4,722 (2,373 females) subjects was 6 years 7 months. Overall, the SPOT device referred 563 (11.9 percent) children. There was no significant difference in referral rate based on sex (p = 0.598). Children aged 73-144 months had the highest referral rate (12.2 percent) and children aged 12-30 months had the lowest referral rate (7.9 percent). The suspected reasons for referral based upon the screenings were as follows: 371 (7.9 percent) astigmatism, 24 (0.5 percent) ocular misalignment, 101 (2.1 percent) anisometropia, 135 (2.9 percent) myopia, 36 (0.8 percent) hyperopia, and 16 (0.3 percent) anisocoria. CONCLUSIONS: The SPOT photoscreener yielded an acceptable referral rate of 11.9 percent. This study represents an effective model for pediatric vision screening in South Dakota.