Comparison of Visual Outcomes and Patient Satisfaction in Mild to Moderate Glaucoma Patients Undergoing Cataract Surgery With EDOF Versus Monofocal IOLs

Summary

Cataract is the leading cause of reversible vision loss, while glaucoma remains the primary cause of irreversible blindness, often impairing contrast sensitivity (CS), glare tolerance, and dark adaptation. These visual challenges are particularly relevant when selecting intraocular lenses (IOLs) for glaucoma patients undergoing cataract surgery.

Monofocal IOLs are the safest and most commonly used option for glaucoma patients due to their optical simplicity and low incidence of photic phenomena, though they do not provide spectacle independence for near or intermediate vision. Multifocal IOLs (MFIOLs), while offering greater spectacle independence, are relatively contraindicated in glaucoma due to increased visual disturbances like glare and halos.

Extended Depth of Focus (EDOF) IOLs offer an intermediate solution, using advanced optics to provide a continuous range of vision and fewer photic disturbances than MFIOLs. EDOF lenses have demonstrated good uncorrected distance and intermediate visual acuity in patients with mild to moderate glaucoma, with promising CS outcomes and high patient satisfaction. However, findings on CS performance remain inconsistent across studies.

Given these considerations, this study seeks to determine whether EDOF IOLs can be a viable alternative to monofocal lenses in glaucoma patients, potentially expanding their options for spectacle independence without compromising visual quality. The trial, conducted at OMIQ (Barcelona), will directly compare an EDOF IOL and a monofocal IOL made from the same material to assess their effects on visual acuity, contrast sensitivity, and photic phenomena in this specific patient population.

Conditions

• GLAUCOMA 1, OPEN ANGLE, D (Disorder)
• Cataract

Interventions

PROCEDURE

Cataract surgery (Monofocal intraocular lens implantation)

This intervention consists of bilateral cataract surgery, a microsurgical procedure in which the eye's natural, clouded lens is removed and replaced with an artificial intraocular lens (IOL) to restore clear vision. In this study, patients with early to moderate primary open-angle glaucoma (POAG) will receive either a monofocal or extended depth-of-focus (EDOF) IOL. The surgical technique involves standard phacoemulsification through a small corneal incision, followed by IOL implantation into the capsular bag. What distinguishes this intervention from others is the glaucoma-specific population, with perioperative protocols designed to minimize intraocular pressure fluctuations and preserve optic nerve function. Additionally, both IOLs share the same material and platform, allowing for an isolated comparison of optical design effects.

PROCEDURE

cataract surgery (Extended depht of focus intraocular lens implantation)

This intervention consists of bilateral cataract surgery, a microsurgical procedure in which the eye's natural, clouded lens is removed and replaced with an artificial intraocular lens (IOL) to restore clear vision. In this study, patients with early to moderate primary open-angle glaucoma (POAG) will receive either a monofocal or extended depth-of-focus (EDOF) IOL. The surgical technique involves standard phacoemulsification through a small corneal incision, followed by IOL implantation into the capsular bag. What distinguishes this intervention from others is the glaucoma-specific population, with perioperative protocols designed to minimize intraocular pressure fluctuations and preserve optic nerve function. Additionally, both IOLs share the same material and platform, allowing for an isolated comparison of optical design effects.

Sponsors & Collaborators

• OMIQ Research

  lead NETWORK

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-31

Primary Completion

2027-02-28

Completion

2027-02-28