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

Primary Purpose

Glaucoma, Open-Angle, Cataract

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vivity IOL
Sponsored by
Vold Vision P.L.L.C
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring Glaucoma, Cataract, Microstent, Premium IOL

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

  • Vold Vision P.L.L.C.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR
Visual acuity measurement
Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
Visual acuity measurement
Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR
Visual acuity measurement
Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
Visual acuity measurement
Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR
Visual acuity measurement
Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
Visual acuity measurement
Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR
Visual acuity measurement
Mean Refractive Spherical Equivalent
Average refractive error or residual spectacle prescription remaining following procedure (diopters)
Mean Absolute Prediction Error
Average prescription remaining compared to preoperative prediction (diopters)
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

Full Information

First Posted
November 6, 2022
Last Updated
May 5, 2023
Sponsor
Vold Vision P.L.L.C
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT05624398
Brief Title
Results of Patients With Glaucoma Undergoing Minimally Invasive Glaucoma Surgery in Conjunction With Cataract Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vold Vision P.L.L.C
Collaborators
Alcon Research

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Cataract
Keywords
Glaucoma, Cataract, Microstent, Premium IOL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, single-center, single-surgeon, single-arm, descriptive study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Subjects implanted with the Vivity IOL undergoing concurrent implantation of the Hydrus Microstent
Intervention Type
Device
Intervention Name(s)
Vivity IOL
Other Intervention Name(s)
Hydrus Microstent
Intervention Description
Cataract surgery with implantation of the Vivity IOL along with concurrent implantation of the Hydrus Microstent
Primary Outcome Measure Information:
Title
Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
Description
Visual acuity measurement
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR
Description
Visual acuity measurement
Time Frame
3 months
Title
Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
Description
Visual acuity measurement
Time Frame
3 months
Title
Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR
Description
Visual acuity measurement
Time Frame
3 months
Title
Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
Description
Visual acuity measurement
Time Frame
3 months
Title
Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR
Description
Visual acuity measurement
Time Frame
3 months
Title
Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
Description
Visual acuity measurement
Time Frame
3 months
Title
Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR
Description
Visual acuity measurement
Time Frame
3 months
Title
Mean Refractive Spherical Equivalent
Description
Average refractive error or residual spectacle prescription remaining following procedure (diopters)
Time Frame
3 months
Title
Mean Absolute Prediction Error
Description
Average prescription remaining compared to preoperative prediction (diopters)
Time Frame
3 months
Title
Mean post-op refractive astigmatism and the distribution of post-op refractive astigmatism at ≤0.25D, ≤0.50D, ≤0.75D, and ≤1.00D
Description
Examining the distribution or remaining astigmatism in subjects
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Mean Photopic Monocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR
Description
Visual acuity measurement
Time Frame
3 months
Title
Mean Photopic Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR
Description
Visual acuity measurement
Time Frame
3 months
Title
Mean Photopic Binocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR
Description
Visual acuity measurement
Time Frame
3 months
Title
Mean Photopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMAR
Description
Visual acuity measurement using "faded" letters
Time Frame
3 months
Title
Mean Mesopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMAR
Description
Visual acuity measurement using "faded" letters
Time Frame
3 months
Title
Quality of Vision Questionnaire (QoV)
Description
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.
Time Frame
3 months
Title
IOL patient satisfaction (IOLSAT) questionnaire
Description
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.
Time Frame
3 months
Title
Mean preoperative IOP versus postoperative IOP
Description
Comparing intraocular pressure before versus after intervention
Time Frame
3 months
Title
Mean preoperative medications versus postoperative medications
Description
Comparing the amount of preoperative glaucoma medications before versus after intervention
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Vold Vision P.L.L.C.
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael R. M OD
Phone
479-442-8653
Email
mmcfarland@voldvision.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators do not plan to share IPD

Learn more about this trial

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

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