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Results of Patients With Glaucoma Undergoing Minimally Invasive Glaucoma Surgery in Conjunction With Cataract Surgery | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT05624398•Vold Vision P.L.L.C

View on ClinicalTrials.gov

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.

Detailed Description

To evaluate the range of vision and patient reported outcomes in subjects implanted with Clareon Vivity IOL undergoing concurrent MIGS with the Hydrus Microstent

Eligibility

Age

45 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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
+8 more criteria

Locations (1)

Vold Vision P.L.L.C.

Fayetteville, Arkansas, United States

Key Dates

Start Date

December 7, 2022

Primary Completion Date

February 1, 2025

Completion Date

May 1, 2025

Last Updated

August 13, 2024

Enrollment

ESTIMATED participants

Conditions

Glaucoma, Open-AngleCataract

Interventions

Vivity IOL

DEVICE

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

NCT06979752

Glaucoma, Open Angle, Pseudo-exfoliativeCataract

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RECRUITING

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

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Cataract Surgery

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

IC-8 Apthera IOL New Enrollment Post Approval Study

HUD Surgical Guidance for Toric Alignment

PRO-232 in Patients Subjected to Cataract Surgery

Feasibility Clinical Evaluation of the Calibreye System