Results of Patients With Glaucoma Undergoing Minimally Invasive Glaucoma Surgery in Conjunction With Cataract Surgery

NCT05624398 | Recruiting FDA Device

• 1 other identifier: Vivity Protocol 001, Rev A
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to determine how well patients with glaucoma can see following cataract surgery with a special type of lens called an extended-depth-of-focus (EDOF) lens. This lens is intended to reduced the patients need for glasses following cataract surgery. Patients will also undergo a minimally invasive type of glaucoma surgery using a special type of stent to reduce eye pressure, with the goal of better glaucoma control and the reduction in the need for medications to control eye pressure.

Conditions

Glaucoma, Open-Angle; Cataract

Keywords

Glaucoma; Cataract; Microstent; Premium IOL

Outcome Measures

Primary Outcomes (1)

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

  Visual acuity measurement

  3 months

Secondary Outcomes (10)

• Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR

  3 months

• Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR

  3 months

• Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR

  3 months

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

  3 months

• Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR

  3 months

Other Outcomes (9)

• Mean Photopic Monocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR

  3 months

• Mean Photopic Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR

  3 months

• Mean Photopic Binocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR

  3 months

Study Arms (1)

Treatment Group

EXPERIMENTAL

Subjects implanted with the Vivity IOL undergoing concurrent implantation of the Hydrus Microstent

Device: Vivity IOL

Interventions

Vivity IOL DEVICE

Cataract surgery with implantation of the Vivity IOL along with concurrent implantation of the Hydrus Microstent

Also known as: Hydrus Microstent

Treatment Group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vold Vision P.L.L.C: lead
• Alcon Research: collaborator

Study Sites (1)

Vold Vision P.L.L.C.

Fayetteville, Arkansas, 72764, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Cataract; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lens Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-center, single-surgeon, single-arm, descriptive study

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: November 22, 2022
• Study Start: December 7, 2022
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)