Efficacy and Safety of Lens Extraction in Patients With Pseudoexfoliation Glaucoma
Pseudoexfoliation Glaucoma, Intraocular Pressure
About this trial
This is an interventional treatment trial for Pseudoexfoliation Glaucoma
Eligibility Criteria
Inclusion criteria:
- Presence of cataract with visual symptoms that justify the intervention, such as photophobia, difficulty in activities of daily living or driving.
Mild or moderate PXF glaucoma or ocular hypertension (OHT) over 25mmHg + PXF syndrome.
Glaucoma is defined as: reproducible defects (two or more contiguous points with a loss of P <0.01, three or more contiguous points with a loss of P <0.05 or greater) in the visual field (VF) or , ophthalmoscopically detectable damage to the optic nerve (cup disc ratio> or = 0.7 and / or focal thinning of the optic nerve rim and / or asymmetry of cup disc ratio > or = 0.2 between both eyes).
PXF is defined clinically by the presence of pseudoexfoliative material in the anterior capsule of the lens.
Mild glaucoma is defined as MD< 6dB. Moderate glaucoma is defined as MD < 12dB.
- Naive patients or without topical hypotensive treatment in the last 3 months.
- Age: patients > 60 years.
- Best corrected visual acuity (BCVA) between range > 0.4 and <0.7
- Signature of the specific informed consent of the study.
Exclusion criteria:
- Advanced glaucoma. It is defined as an average deviation > -15dB and / or threat of fixation (paracentral point with sensitivity of 0 dB), and / or cup disc ratio > 0.9
- Corneal edema, corneal opacity or any other known corneal factor that may increase the risk of complications during surgery
- Previous cataract surgery in the eye included in the study
- Axial length <20 mm
- Estimated IOL power> 30 diopters
- Visual acuity <0.4 or> 0.7
- Signs of zonular weakness: phacodonesis, iridodonesis, lens subluxation, asymmetry of anterior chamber depth
- Pupillary dilation <5 mm
- Advanced cataract
Sites / Locations
- Sara Pose-Bazarra
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
MEDICAL TREATMENT GROUP
INTERVENTION GROUP
Medical treatment will be used in a staggered manner and may also associate laser trabeculoplasty. If necessary, then surgical treatment would be indicated: trabeculectomy. or another filtering surgery. Inadequate IOP control will be determined by the local ophthalmologist, and additional treatment will be indicated to achieve an target IOP.
In lens extraction arm, patients will undergo lens phacoemulsification with intraocular lens implant (IOL) within 60 days after randomization. If additional treatment is required, the same stepped sequence of therapy described for "medical treatment group" will be used and will be considered a therapeutic failure.