Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial.

BACKGROUND/AIMS: The current study evaluates the efficacy and safety of the stand-alone implantation of the MINIject (iSTAR Medical, Wavre, Belgium) supraciliary, microinvasive glaucoma drainage device in patients with medically uncontrolled open-angle glaucoma. METHODS: This prospective, multicentre, first-in-human, single-arm interventional study evaluated stand-alone, ab interno implantation in 25 patients of a 5 mm long uveoscleral device made of STAR biocompatible material, which is a soft, microporous, flexible silicone. The primary outcome was the reduction of intraocular pressure (IOP) at 6 months compared with baseline, and follow-up continued until 2 years for 21 patients. Secondary outcomes included success defined as diurnal IOP of ≤21 mmHg and >5 mmHg with an IOP reduction of 20% without (complete) or with/without (qualified) glaucoma medication. RESULTS: Mean baseline IOP was 23.2±2.9 mmHg on 2.0±1.1 glaucoma medication ingredients and decreased to 13.8±3.5 mmHg (-40.7% reduction) on 1.0±1.3 medications 2 years after implantation. Complete success was achieved in 47.6% of patients (10/21) and qualified success in 100% of patients (21/21) at the 2-year follow-up. All patients achieved a 20% IOP reduction with 48% of patients medication-free. No serious ocular adverse events or additional glaucoma surgery were reported. Mean central endothelial cell density (ECD) mildly decreased from 2411 cells/mm2 (n=26) to 2341 cells/mm2 (n=21) at 24 months, which represents a 5% decrease for matched eyes. No patient had a ≥30% decrease in central ECD. CONCLUSION: This first-in-human study on the stand-alone implantation of the MINIject supraciliary drainage system shows promising IOP-lowering results and medication reduction over 24 months with few adverse events. TRIAL REGISTRATION NUMBER: NCT03193736.

A First-in-Human Study of the Efficacy and Safety of MINIject in Patients with Medically Uncontrolled Open-Angle Glaucoma (STAR-I).

PURPOSE: To describe the safety and efficacy of a novel, supraciliary, microinvasive glaucoma surgery drainage system, MINIject (iSTAR Medical, Wavre, Belgium), in the study. DESIGN: Prospective, multicenter, interventional, single-arm trial. PARTICIPANTS: Twenty-six patients with primary open-angle glaucoma uncontrolled with 1 or more intraocular pressure (IOP)-lowering medications. METHODS: Using an ab interno approach, 25 eyes were implanted successfully in a stand-alone procedure with a 5-mm long device made of biocompatible STAR material, which is soft and flexible silicone in a microporous, network design. Intraocular pressure, medication use, and other ocular parameters were evaluated before surgery, 1 day, 1 and 2 weeks, and 1, 3, and 6 months after surgery. MAIN OUTCOME MEASURES: Intraocular pressure reduction at 6 months compared with baseline analyzed using a paired t test. Safety evaluation entailed tabulation of the nature and frequency of adverse events. RESULTS: Mean baseline diurnal IOP was 23.2 mmHg (standard error, 0.6 mmHg) using a mean ± standard deviation of 2.0±1.1 IOP-lowering medication classes. During the 6-month follow-up period, mean IOP ranged from 10.0-16.3 mmHg (mean reductions, 6.9-13.2 mmHg or 31.0%-56.8%). Six months after surgery, mean diurnal IOP was 14.2 mmHg (standard error, 0.9 mmHg), equivalent to a reduction of 9.0 mmHg or 39.1% (P < 0.0001). The mean ± standard deviation number of IOP-lowering medications was 0.3±0.7. Of 24 patients seen at 6-month follow-up, 21 (87.5%) were medication-free and 23 (95.8%) achieved a minimum 20% IOP reduction from baseline. There were no serious adverse events related to the device or procedure, and no additional glaucoma surgery was required. Frequently reported events included anterior chamber inflammation (n = 8), IOP elevation (n = 6), of which 1 event was an IOP spike per protocol, visual acuity reduction (n = 3), and hyphema (n = 3), all of which resolved. There was no change to mean central or peripheral corneal endothelial cell density. No device-related adverse events were reported. CONCLUSIONS: The MINIject glaucoma drainage system significantly lowered IOP and eliminated the need for medication in most patients 6 months after surgery when implanted in a standalone procedure. There were no serious ocular adverse events.

Application of high intensity focused ultrasound for treatment of open-angle glaucoma in Indian patients.

Purpose: The aim of this study is to assess the efficacy of ultrasound cycloplasty (UCP) in Indian patients with open angle glaucoma (OAG). Methods: A prospective interventional study was designed to treat 73 eyes of 73 patients with OAG with the EyeOP1 device equipped with six miniaturized cylindrical piezoelectric transducers. Two treatment protocols of ultrasound delivery depending on exposure time (8 s and 10 s of shot per transducer) were used. Complete ophthalmic examination, ocular biometry and anterior segment optical coherence tomography were performed preoperatively and patients were followed up at day 1, day 7 and months 1, 2, 3, 6, and 12. The primary outcome measure was "successful" intraocular pressure (IOP) control defined as IOP reduction ≥20% from baseline and IOP value >5 mm Hg at the last follow-up visit. Secondary outcomes were the occurrence of complications and mean IOP during the follow-up period. Results: In all patients, the mean IOP reduced from 23.5 ± 3.0 mmHg before treatment to 15.7 ± 5.4 mmHg at 12 months (P < 0.05). Successful IOP control after a single procedure was 78.3% (79% and 78% in the 8 s and 10 s groups, respectively) at 12 months. Overall, the mean IOP reduction achieved in responding patients was 41% (standard deviation = 12%). Notwithstanding minor side effects such as transient pain, anterior chamber reaction, and refractive error changes, no major intraoperative or postoperative complications (severe hypotony or phthisis) were observed during the follow-up. Conclusion: Our short-term results reveal that UCP is a simple, safe, and noninvasive procedure which enables to significantly reduce the IOP in patients with OAG. The study results in Indian eyes corroborate findings in earlier studies on Caucasian eyes.

Effectiveness and safety of femtosecond laser-assisted lens fragmentation and anterior capsulotomy versus the manual technique in cataract surgery.

PURPOSE: To evaluate the effectiveness and safety of cataract surgery using femtosecond laser-assisted lens fragmentation and anterior capsulotomy versus manual cataract surgery. SETTING: MaxiVision Eye Hospital, Begumpet, Hyderabad, India. DESIGN: Randomized controlled open-label multisurgeon prospective trial. METHODS: Patients (at least 18 years old) were randomized to femtosecond laser-assisted lens prefragmentation and capsulotomy or manual capsulorhexis and standard phacoemulsification. Measured outcomes were effective phacoemulsification time (EPT), surgeon-assessed ease of phacoemulsification, mean phaco energy, mean phaco time, balanced salt solution volume, capsulotomy precision, and adverse event rates. RESULTS: Fifty-six eyes had the femtosecond laser procedure, and 63 had manual cataract surgery. The mean EPT was significantly lower in the laser group (5.2 seconds ± 5.7 [SD]) than in the manual group (7.7 ± 6.0 seconds) (P=.025). There was a significant difference in the mean phaco energy between the 2 groups (13.8% ± 10.3% in laser group; 20.3% ± 8.1% in manual group) (P<.001). There were no significant between-group differences in the ease of phacoemulsification, mean phaco time, or balanced salt solution volume. Laser-assisted capsulotomies were significantly more accurate and precise (intended diameter, circularity, centration) (P<.01). The safety profiles of the procedures were equivalent, with no adverse events at the 1-day follow-up. CONCLUSION: The femtosecond laser platform was effective and safe in cataract surgery, reducing EPT and the mean phaco energy during lens fragmentation and providing precise and reproducible capsulotomies.

Comparison of the maximum applicable stretch force after femtosecond laser-assisted and manual anterior capsulotomy.

PURPOSE: To objectively measure the strength of the capsulotomy performed with a femtosecond laser-assisted technique or performed manually in a pig-eye laboratory study. SETTING: International Vision Correction Research Centre, Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany. DESIGN: Experimental study. METHODS: Ten fresh pig eyes were randomly assigned to femtosecond laser-assisted capsulotomy or manual capsulotomy. The capsule was immersed in hyaluronic acid, and retractors were fixed in the capsule opening with a pull-force measuring device. The force necessary to break the capsulotomy was measured in millinewtons (mN); the maximum stretching ratio was also assessed. RESULTS: The observed mean rupture force (ie, maximum amount of force measured immediately before tissue rupture) was 113 mN ± 12 (SD) in the laser-assisted procedure and 73 ± 22 mN in the manual procedure (P<.05). The stretching ratios were 1.60 ± 0.10 (femtosecond) and 1.35 ± 0.04 (manual) (P<.05). CONCLUSION: In this laboratory pig-eye study, femtosecond laser-assisted capsulotomy resulted in a significantly stronger anterior capsule opening than the standard manually performed capsulotomy.

Posterior chamber toric phakic intraocular lenses for myopic astigmatism: first experience in India.

PURPOSE: To evaluate the efficacy and safety of the toric Implantable Collamer Lens phakic intraocular lens (pIOL) in the management of myopic astigmatism in Indian eyes. SETTING: Tertiary eyecare center, South India. DESIGN: Retrospective interventional case series. METHODS: The study included consecutive patients with myopic astigmatism with a minimum follow-up of 1 year. Safety, efficacy, predictability, and adverse events were assessed preoperatively and 12 months postoperatively. RESULTS: The study enrolled 110 eyes (65 patients). The mean corrected distance visual acuity was 0.23 logMAR ± 0.23 (SD) preoperatively and 0.18 ± 0.18 logMAR 12 months postoperatively (P<.001). The mean refractive cylinder decreased from 2.3 ± 1.1 diopters (D) to 0.4 ± 0.6 D, respectively (P<.001). Postoperatively, the uncorrected distance visual acuity improved to 20/20 in 15 eyes (13.6%) and 20/40 or better in 72 eyes (65.4%). Fourteen eyes (12.7%) gained 2 or more lines of corrected distance visual acuity, 21 eyes (19.1%) gained 1 line, 61 eyes (55.5%) had no change, and 1 eye (0.9%) lost 2 lines. Predictability within ±0.50 D of cylinder was achieved in 77 eyes (70 %) and within ±1.00 D in 97 eyes (88.2%). Twelve months postoperatively, the safety index was 0.75 and the efficacy index was 1.04. Endothelial cell loss at the end of 12 months was 10.3%. Clinically significant cataract developed in 1 eye (0.9%). CONCLUSION: Implantation of posterior chamber toric pIOLs to correct myopic astigmatism was effective, safe, and predictable.

Association of vitamin D receptor gene start codon (Fok1) polymorphism with high myopia.

BACKGROUND: High myopia caused primarily due to abnormal emmetropization and excessive axial ocular elongation is associated with sight-threatening ocular pathology. Muscular dysfunction of ocular ciliary muscles due to altered intracellular calcium levels can result in defective mechanotransduction of the eye and retinal defocus. The vitamin D3 receptor (VDR; a intracellular hormone receptor) is known to mediate calcium homeostasis, influencing the development of myopia. MATERIALS AND METHODS: In the present study, a total of 206 high myopia, 98 low myopia and 250 control samples were analyzed for VDR gene Fok1 (exon 2 start codon) polymorphism using polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) technique. RESULTS: High myopia patients revealed decrease in the frequency of ff homozygotes (8.3%) as compared to control group (14.0%), with a corresponding increase in frequency of FF homozygotes (68.9% in high myopia vs. 62.8% in controls). The frequency of f allele carriers (Ff and ff) was increased in females of high myopia (35.6%) and low myopia cases (45.4%). Elevated frequency of f allele was found only in early age at onset cases of high myopia (0.227) and later age at onset (10-20 years) cases of low myopia (0.273) as well as in low myopia cases with parental consanguinity (0.458) (P 0.035; χ(2) = 6.692*). CONCLUSION: The results suggest that VDR gene might not be playing a direct role in the development of myopia, but might contribute indirectly to the risk conferred by mechanical stress factors or growth/development related factors through its role in calcium homeostasis and regulation of ciliary muscle function.

A retrospective analysis of the first Indian experience on Artisan phakic intraocular lens.

PURPOSE: To evaluate the efficacy, safety, predictability and stability of implanting a polymethylmethacrylate phakic intraocular lens (PIOL) in high myopia. MATERIALS AND METHODS: A retrospective analysis of the data of patients who underwent Artisan phakic IOL implantation between 2002 and 2003 with a follow-up of at least 24 months. RESULTS: An Artisan myopia lens was implanted in 60 eyes of 36 patients with preoperative myopia ranging from -5.0 to -24.0 D. Mean patient age was 22.6 years. Mean spherical equivalent of manifest refraction stabilized by the first postoperative week. At three months follow-up, 54 eyes (90%) had a postoperative refraction within +/- 1D emmetropia and 45 eyes (75%) had uncorrected visual acuity of 20/40 or better. Seven eyes (11.6%) had loss of one Snellen line and none had loss of two Snellen lines or more at three months. The mean endothelial cell loss was 3.8% at three months, 5.2% at six months, 5.25% at 12 months and 6.38% at two years, which was not significant. Postoperative complications included anterior chamber reaction in two eyes (3.3%), rise in intraocular pressure in six eyes (10%) and dislocation of PIOL in two eyes (3.3%). CONCLUSION: Implantation of Artisan myopia lens to correct high myopia resulted in a stable and fairly predictable refractive outcome with few complications. Significant endothelial damage was not detected in two years of follow-up.