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

NCT07436871 | Not Yet Recruiting DMC

• 1 other identifier: VOR2024-CG-001
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief 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

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

Keywords

cataract surgery; Extended depth of focus intraocular lens; Primary open-angle glaucoma

Outcome Measures

Primary Outcomes (1)

• Binocular distance-corrected intermediate visual acuity (DCIVA)

  The comparison of the binocular, distance-corrected intermediate visual acuity (bDCIVA) between groups at month 3. For the visual acuity assessments in this study, measurements will be expressed using LogMAR (Logarithm of the Minimum Angle of Resolution) units. The LogMAR scale provides a standardized way to quantify visual acuity, with higher values indicating worse vision. The range of LogMAR units typically spans from -0.3 (indicating excellent vision) to +2.0 (indicating severe visual impairment), ensuring a comprehensive evaluation of participants' visual performance.

  3 months

Secondary Outcomes (11)

• bUDVA, bUIVA, bUNVA, bDCVA and bDCNVA

  3 months

• mUDVA, mUIVA, mUNVA, mDCDVA, mDCIVA and mDCNVA

  3 months

• Defocus curve

  3 months

• Mesopic and photopic contrast sensitivity

  3 months

• Visual field stability

  3 months

Other Outcomes (6)

• Safety endpoints

  up to 3 months

• Safety endpoints

  up to 3 months

• Safety endpoints

  up to 3 months

Study Arms (2)

cataract, glaucoma, monofocal intraocular lens

ACTIVE COMPARATOR

Bilateral cataract surgery in patients with primary open-angle glaucoma receiving monofocal intraocular lens implantation (n = 37 in this study arm).

Procedure: Cataract surgery (Monofocal intraocular lens implantation)

cataract, glaucoma, Extended range of focus intraocular lens

EXPERIMENTAL

Bilateral cataract surgery in patients with primary open-angle glaucoma receiving extended range of focus intraocular lens implantation (n = 37 in this study arm).

Procedure: cataract surgery (Extended depht of focus intraocular lens implantation)

Interventions

Cataract surgery (Monofocal intraocular lens implantation) PROCEDURE

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.

cataract, glaucoma, monofocal intraocular lens

cataract surgery (Extended depht of focus intraocular lens implantation) PROCEDURE

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.

cataract, glaucoma, Extended range of focus intraocular lens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of any sex aged 18 years or older willing to participate and sign the informed consent form.
• Clinically significant cataracts in both eyes.
• Patients clinically diagnosed of primary open angle glaucoma (POAG) in both eyes.
• Early to moderate POAG, as defined by a mean deviation in the Humphrey Visual Field Analyzer (HFA) no worse than ≤ -12 dB and worse ≥ -2 dB at least in one eye, using a 24-2 SITA standard strategy
• Two visual field tests without progression and stability of RNFL in Optical Coherence Tomography (OCT) thickness remaining same or less than 10 um in the previous 6 months, with pharmacologically controlled IOP in both eyes \<21mmHg.
• Potential for post-surgery monocular distance corrected visual acuity of ≤ 0.10 LogMAR.
• Normal corneal topography.
• Able to attend all study visits.

You may not qualify if:

• Patients with uncontrolled glaucoma, defined as those with an IOP ≥21 mm Hg despite maximal medical therapy, requiring glaucoma surgery and/or laser in either eye in the next year.
• Pre-surgery refractive error requiring IOL implantation beyond the commercially available range.
• Patients with a not reliable visual field, a VFI ≤ 60% or defects of ≤ 10 dB in the 4 central points of the visual field.
• Any other form of glaucoma (pseudoexfoliative, severe forms of pigmentary, primary angle closure glaucoma, etc.), ocular hypertension, zonular instability or possible intuitive lens decentration after surgery.
• Patients with any previous glaucoma surgery or any other ocular surgery that can affect the results, or any ocular surgery in the previous six months.
• Any other ocular pathology that can affect the results.
• Use of topic or systemic medication that may affect vision
• Unable to cooperate to obtain consistent testing results.
• Participation in any other trial during or within 30 days of the screening visit.

Sponsors & Collaborators

• OMIQ Research: lead

MeSH Terms

Conditions

Cataract; Glaucoma, Open-Angle

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Glaucoma; Ocular Hypertension

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: A prospective, patient and evaluator-masked, interventional, double-arm, randomized clinical trial (RCT), 3-month follow-up study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 27, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02