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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.
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.
Details
| Lead sponsor | OMIQ Research |
|---|---|
| Phase | NA |
| Status | NOT_YET_RECRUITING |
| Enrolment | 74 |
| Start date | 2026-01-31 |
| Completion | 2027-02 |
Conditions
- GLAUCOMA 1, OPEN ANGLE, D (Disorder)
- Cataract
Interventions
- Cataract surgery (Monofocal intraocular lens implantation)
- cataract surgery (Extended depht of focus intraocular lens implantation)
Primary outcomes
- Binocular distance-corrected intermediate visual acuity (DCIVA) — 3 months
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.