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

Sponsor

Vold Vision P.L.L.C (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05624398

Collaborator

Alcon Research (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle Cataract	Device: Vivity IOL	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective, single-center, single-surgeon, single-arm, descriptive studyProspective, single-center, single-surgeon, single-arm, descriptive study

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Nov 30, 2022

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR [3 months]
Visual acuity measurement

Secondary Outcome Measures

Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR [3 months]
Visual acuity measurement
Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR [3 months]
Visual acuity measurement
Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR [3 months]
Visual acuity measurement
Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR [3 months]
Visual acuity measurement
Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR [3 months]
Visual acuity measurement
Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR [3 months]
Visual acuity measurement
Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR [3 months]
Visual acuity measurement
Mean Refractive Spherical Equivalent [3 months]
Average refractive error or residual spectacle prescription remaining following procedure (diopters)
Mean Absolute Prediction Error [3 months]
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 [3 months]
Examining the distribution or remaining astigmatism in subjects

Other Outcome Measures

Mean Photopic Monocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR [3 months]
Visual acuity measurement
Mean Photopic Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR [3 months]
Visual acuity measurement
Mean Photopic Binocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR [3 months]
Visual acuity measurement
Mean Photopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMAR [3 months]
Visual acuity measurement using "faded" letters
Mean Mesopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMAR [3 months]
Visual acuity measurement using "faded" letters
Quality of Vision Questionnaire (QoV) [3 months]
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.
IOL patient satisfaction (IOLSAT) questionnaire [3 months]
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.
Mean preoperative IOP versus postoperative IOP [3 months]
Comparing intraocular pressure before versus after intervention
Mean preoperative medications versus postoperative medications [3 months]
Comparing the amount of preoperative glaucoma medications before versus after intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts 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