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.
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
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.
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.
Parallel
Cataract surgery (Monofocal intraocular lens implantation)
Procedure/SurgeryThis 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 surgery (Extended depht of focus intraocular lens implantation)
Procedure/SurgeryThis 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.
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.
bUDVA, bUIVA, bUNVA, bDCVA and bDCNVA
The binocular, uncorrected and distance-corrected distance, intermediate (66 cm) and near (40 cm) visual acuities (bUDVA, bUIVA, bUNVA, bDCVA and bDCNVA, respectively) in 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.
mUDVA, mUIVA, mUNVA, mDCDVA, mDCIVA and mDCNVA
he monocular, uncorrected and corrected distance, intermediate (66 cm) and near (40 cm) visual acuity (mUDVA, mUIVA, mUNVA, mDCDVA, mDCIVA and mDCNVA, respectively) in 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.
Defocus curve
Defocus curve performance at month 3 The defocus curve typically uses diopters (D) as its unit of measurement. Diopters quantify the optical power of a lens and are used to assess how well a person's vision performs across different focus levels (with a scale that typically ranges from -5.00 D to +2.00 D), indicating the clarity of vision at varying distances.
Mesopic and photopic contrast sensitivity
Distance-corrected binocular contrast sensitivity in photopic and mesopic conditions before the surgery and at month 3. Contrast sensitivity is typically measured using the logarithm of contrast sensitivity (log CS), with a scale that generally ranges from 0 to 3.0. Values close to 3.0 indicate excellent contrast sensitivity, while values closer to 0 suggest significantly diminished contrast sensitivity. In some tests, results may also be reported as decimal values or percentages, where higher values correspond to a better ability to detect low-contrast stimuli. This comprehensive scale allows for an effective evaluation of a person's visual performance in varying lighting and contrast conditions.
Safety endpoints
The safety endpoints of the study will include IOP ≤ 25 mm Hg. The scale for intraocular pressure generally ranges from about 10 mmHg to 21 mmHg in healthy eyes, though values above 21 mmHg are often considered elevated. However, following certain surgical procedures, IOP may rise above 25 mmHg due to expected alterations in fluid dynamics within the eye and as a result of steroid therapy administered as a standard postoperative treatment.
Safety endpoints
Anterior segment adverse event. Anterior segment analysis using a slit lamp is typically assessed without specific units of measurement, as it primarily involves visual and qualitative evaluations of the structures, by the physician, within the anterior segment of the eye.
Safety endpoints
Posterior segment adverse event Posterior segment analysis using a slit lamp, often enhanced with specialized lenses, is primarily conducted through visual and qualitative evaluations by the physician, without the use of specific units of measurement. This examination focuses on assessing the various structures within the posterior segment of the eye. The findings are typically reported descriptively based on the physician's observations and assessments of the anatomical features and any abnormalities present.
Safety endpoints
Visual field worsening Visual field worsening is generally measured using decibels (dB) in the context of perimetry tests, which quantify the sensitivity of the visual field at various points. Lower decibel values indicate poorer sensitivity and greater visual field loss. The Visual Field Index (VFI) is another important measurement used to assess visual field performance, typically expressed as a percentage ranging from 0% to 100%. A VFI of 100% indicates a full visual field with no loss, while lower percentages reflect varying degrees of visual field impairment.
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