NCT07436871Not yet recruiting
Comparison of Visual Outcomes and Patient Satisfaction in Mild to Moderate Glaucoma Patients Undergoing Cataract Surgery With EDOF Versus Monofocal IOLs
A Randomized Clinical Trial for the Evaluation and Comparison of Visual Results and Patient Satisfaction in Patients With Primary Open-angle Glaucoma After Bilateral Implantation of an Extended Range of Vision Intraocular Lens Compared to a Monofocal Lens.
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 74 (estimated)
- First submitted
- 30 Jan 2026
- Start date
- 31 Jan 2026
- Primary completion date
- Feb 2027
- Lead sponsor
- OMIQ Research
- Diseases
- Glaucoma
- NCT number
- NCT07436871
What you commit to
- Study type: Interventional
- Planned participants: 74
- From 31 Jan 2026 to the primary completion date, Feb 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 any previous glaucoma surgery or any other ocular surgery that can affect the results, or any ocular surgery in the previous six months.
- Use of topic or systemic medication that may affect vision
Other illness
- 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.
Other
- Any other ocular pathology that can affect the results.
- Unable to cooperate to obtain consistent testing results.
- Participation in any other trial during or within 30 days of the screening visit.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.