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

Not Applicable

Completed

• Conditions: Cataract; IOL; Glaucoma, Open-Angle
• Interventions: Procedure: Cataract surgery with implantation of trifocal IOL combined with trabecular scaffold

• Registration Number: NCT04619654
• Lead Sponsor: Vold Vision P.L.L.C

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-06
• Study Start: 2021-02-01
• Status Verified: 2022-05
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Last Update Submitted: 2022-11-06
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cataract Surgery with concurrent MIGS	Cataract surgery with implantation of trifocal IOL combined with trabecular scaffold	-

Primary Outcome Measures

Name	Time	Method
Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR	3 months

Secondary Outcome Measures

Name	Time	Method
Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR	3 months
Mean Photopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar	3 months
Mean Photopic Monocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR	3 months
Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR	3 months
Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR	3 months
Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR	3 months
Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR	3 months
Mean Photopic Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR	3 months
Mean Photopic Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR	3 months
Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR	3 months
Mean Photopic Binocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR	3 months
Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR	3 months
Mean Mesopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar	3 months

Trial Locations

Locations (1)

Vold Vision P.L.L.C.; 🇺🇸 Fayetteville, Arkansas, United States