CompletedNot Applicable

Visual Outcomes With a Trifocal IOL in Subjects With Open-angle Glaucoma

United States25 participantsStarted 2021-02-01

Plain-language summary

This study will examine the visual outcomes of subjects undergoing cataract surgery and minimally invasive glaucoma surgery with the implantation of a trifocal intraocular lens.

Who can participate

Age range45 Years

SexALL

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Inclusion criteria

✓. Male or female subjects 45 years of age or older
✓. A visually significant cataract
✓. Diagnosis of mild OAG
✓. Glaucoma must be judged as stable by investigator based on review of subject medical records
✓. Shaffer grade of greater than III in all quadrants
✓. Potential of good 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

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
✕. 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

What they're measuring

Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR

Timeframe: 3 months

Trial details

NCT IDNCT04619654

SponsorVold Vision P.L.L.C

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-01

View on ClinicalTrials.gov More Cataract trials