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

Vold Vision

Status: Completed

Conditions: Cataract; Glaucoma, Open-Angle; IOL

Treatments: Procedure: Cataract surgery with implantation of trifocal IOL combined with trabecular scaffold

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04619654

PanOptix Trifocal 001, Rev A

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subjects 45 years of age or older

2. A visually significant cataract

3. Diagnosis of mild OAG

   • Vertical C/D ratio of less than or equal to 0.8
   • 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 of less than or equal to mmHg on 1-3 medications
   • If treatment naïve (before glaucoma treatment) IOP between 21 and 35 mmHg

4. 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

5. Shaffer grade of greater than III in all quadrants

6. Potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 logMAR (20/25) postoperatively

7. Able and willing to comply with follow up visits

8. Understands and signs the informed consent

Exclusion criteria

1. Previous incisional glaucoma surgery or cilio-ablative surgery

2. Prior laser trabeculoplasty within 90 days of surgery

3. Pseudoexfoliative, angle closure, uveitic, congenital, traumatic, angle recession, or neovascular glaucoma.

4. Moderate glaucoma with VF mean deviation between -6.00 dB and -12.00 dB

5. 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

6. 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.

7. 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.

8. Pregnant or breastfeeding women

9. Prior refractive surgery e.g. LASIK, RK, PRK, etc.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Cataract Surgery with concurrent MIGS

Experimental group

Treatment:

Procedure: Cataract surgery with implantation of trifocal IOL combined with trabecular scaffold