Improving vision for glaucoma patients undergoing cataract surgery
Visual Outcomes and Patient Satisfaction in Subjects With Stable Open-angle Glaucoma Undergoing Concurrent Minimally Invasive Glaucoma Surgery and IOL Implantation With an Extended-depth-of-focus IOL
This study tests if a special lens can improve vision for glaucoma patients who are having cataract surgery and help them rely less on glasses afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Vold Vision P.L.L.C Academic / other |
| Locations | 1 site (Fayetteville, Arkansas) |
| Trial ID | NCT05624398 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an extended-depth-of-focus lens in patients with glaucoma who are also undergoing cataract surgery. Participants will receive a special type of lens called the Clareon Vivity IOL, alongside a minimally invasive glaucoma surgery using the Hydrus Microstent to help control eye pressure. The study aims to assess visual outcomes and patient-reported experiences following these procedures. By combining these interventions, the study seeks to enhance vision and reduce the need for glasses post-surgery.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 and older with visually significant cataracts and mild open-angle glaucoma.
Not a fit: Patients with advanced glaucoma or those who do not meet the stability criteria for their condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve vision and quality of life for patients with glaucoma and cataracts.
How similar studies have performed: Other studies have shown promising results with similar minimally invasive approaches for glaucoma treatment, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female subjects 45 years of age or older * A visually significant age-related cataract in both eyes * Diagnosis of mild OAG * VF characteristics consistent with glaucoma with mean deviation not worse than -6.00 dB and without fixation threatening scotoma AND/OR with nerve abnormalities consistent with glaucoma (rim notching, rim thinning, disc hemorrhage, nerve fiber layer loss) * Medicated IOP ≤25 mmHg on 1-3 hypotensive medications * Glaucoma must be judged as stable by investigator based on review of subject medical records * Stable VF at least 1 year prior to surgery * Stable nerve fiber layer at least 1 year prior to surgery * IOP stable on current medication regimen at least 3 months prior to surgery * Shaffer grade of ≥ III in all angle quadrants * Potential of best corrected visual acuity at distance in the investigator's judgement of at least 0.1 logMAR (20/25) postoperatively * Able and willing to comply with follow up visits * Understands and signs the informed consent * Both eyes of the subject should undergo surgery within 21 days of each other to ensure adequate timing for final visit window of 90 days ± 21 days post operatively Exclusion Criteria: * Previous incisional glaucoma surgery or cilio-ablative surgery * Prior laser trabeculoplasty within 90 days of surgery * Pseudoexfoliative, angle closure, uveitic, congenital, traumatic, angle recession, or neovascular glaucoma. * Moderate glaucoma with VF mean deviation between -6.00 dB and -12.00 dB * Severe and/or progressive glaucoma defined as * VF mean deviation worse than -12.00 dB * Consistent worsening of visual field on review of subject medical records * Consistent and progressive thinning of nerve fiber layer on review of subject medical records * Uncontrolled IOP on maximum glaucoma medications * Historically poor IOP control with medical therapy * Severe focal notching of the optic nerve rim * Expectation for future need of incisional glaucoma surgery * Ocular pathology or other medical condition which, in the investigator's judgment places the subject at increased risk of complications or significant vision loss during study period * Ocular pathology that in the investigator's judgment may impact visual acuity postoperatively, i.e., significant ocular surface disease, corneal scarring, blepharitis, epiretinal membrane, macular degeneration, history of significant ocular trauma with sequela, etc. * Pregnant or breastfeeding women * Prior refractive surgery e.g., LASIK, RK, PRK, etc. * Subjects with significant complications during surgical procedure e.g., broken capsule, Hydrus Microstent complication, will be exited from the trial * Subjects who experience visually significant complications related to the Hydrus Microstent during the study period will be exited from the trial
Where this trial is running
Fayetteville, Arkansas
- Vold Vision P.L.L.C. — Fayetteville, Arkansas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.