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

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma, Open-Angle; Cataract
• Intervention / Treatment: Device: Vivity IOL

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

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72764
      • Recruiting
      • Vold Vision P.L.L.C.
      • Contact: Michael R. M OD; Phone Number: 479-442-8653; Email: mmcfarland@voldvision.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• 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

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
  • 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
• Prior refractive surgery e.g., LASIK, RK, PRK, etc.
• Subjects with significant complications during surgical procedure e.g., broken capsule, Hydrus Microstent complication, will be exited from the trial
• Subjects who experience visually significant complications related to the Hydrus Microstent during the study period will be exited from the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Subjects implanted with the Vivity IOL undergoing concurrent implantation of the Hydrus Microstent	Device: Vivity IOL; Cataract surgery with implantation of the Vivity IOL along with concurrent implantation of the Hydrus Microstent; Other Names: Hydrus Microstent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR	Visual acuity measurement	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR	Visual acuity measurement	3 months
Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR	Visual acuity measurement	3 months
Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR	Visual acuity measurement	3 months
Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR	Visual acuity measurement	3 months
Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR	Visual acuity measurement	3 months
Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR	Visual acuity measurement	3 months
Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR	Visual acuity measurement	3 months
Mean Refractive Spherical Equivalent	Average refractive error or residual spectacle prescription remaining following procedure (diopters)	3 months
Mean Absolute Prediction Error	Average prescription remaining compared to preoperative prediction (diopters)	3 months
Mean post-op refractive astigmatism and the distribution of post-op refractive astigmatism at ≤0.25D, ≤0.50D, ≤0.75D, and ≤1.00D	Examining the distribution or remaining astigmatism in subjects	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Photopic Monocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR	Visual acuity measurement	3 months
Mean Photopic Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR	Visual acuity measurement	3 months
Mean Photopic Binocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR	Visual acuity measurement	3 months
Mean Photopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMAR	Visual acuity measurement using "faded" letters	3 months
Mean Mesopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMAR	Visual acuity measurement using "faded" letters	3 months
Quality of Vision Questionnaire (QoV)	The QoV is a validated questionnaire designed to determine what if any visual disturbances are present following surgery. It consists of a 30-item instrument with 10 possible symptoms rated in each of 3 scales (frequency, severity, and bothersome). Examples of common visual disturbances include glare and halo. This outcome measure can be graded on a linear scale with a higher score being a worse outcome (more visual disturbances). This questionnaire takes approximately 5 minutes to complete.	3 months
IOL patient satisfaction (IOLSAT) questionnaire	The IOLSAT is a questionnaire inquiring about the need for eyeglasses, vision without eyeglasses, expectations for needed eyeglasses, and visual satisfaction. It consists of 23 questions, the first 21 based on a Likert scale. Questions 22 asks whether the patient would choose the same lens again and 23 if they would recommend the lens to their family and friends.	3 months
Mean preoperative IOP versus postoperative IOP	Comparing intraocular pressure before versus after intervention	3 months
Mean preoperative medications versus postoperative medications	Comparing the amount of preoperative glaucoma medications before versus after intervention	3 months

Collaborators and Investigators

• Sponsor: Vold Vision P.L.L.C
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2022
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: November 6, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 11, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Cataract; Glaucoma; Microstent; Premium IOL
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Lens Diseases; Glaucoma; Glaucoma, Open-Angle; Cataract
• Other Study ID Numbers: Vivity Protocol 001, Rev A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators do not plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes