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

ConditionsGlaucoma, Open-Angle Cataract

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age45+

SponsorVold Vision P.L.L.C

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

25 Participants

are divided into 1 treatment group

Group A: Treatment GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Visual acuity measurement

Time frame

3 months

Secondary outcomes

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

Visual acuity measurement

Time frame

3 months

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

Visual acuity measurement

Time frame

3 months

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

Visual acuity measurement

Time frame

3 months

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

Visual acuity measurement

Time frame

3 months

Other outcomes

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

Visual acuity measurement

Time frame

3 months

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

Visual acuity measurement

Time frame

3 months

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

Visual acuity measurement

Time frame

3 months

Mean Photopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMAR

Visual acuity measurement using "faded" letters

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vold Vision P.L.L.C

Lead sponsor

Alcon Research

Collaborator

Source ClinicalTrials.gov

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