Efficacy and Safety of Lens Extraction in Patients With Pseudoexfoliation Glaucoma

• Status: Completed
• Trial end date: 2021-03-28
• Target enrollment: 0
• Participant gender: All

Summary

There are several publications that have demonstrated the protective role of cataract surgery against the development of long-term glaucoma, especially in cases of pseudoexfoliation glaucoma (PXFG). Cataract surgery in patients with pseudoexfoliation (PXF) is a procedure with higher rates of complications due to its smaller pupillary diameter and its greater zonular weakness, so lens extraction performed earlier could possibly reduce intra and postoperative complications. Given the severity and high prevalence of PXFG in our environment, investigators proposed a randomized clinical trial to evaluate the efficacy of cataract surgery in reducing the intraocular pressure (IOP) at 12 months and thereby change the course of the disease. The control group will have glaucoma treatment according to standard practice.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xerencia de Xestión Integrada de Ferrol
• Collaborators: A.Azuara-Blanco, PhD, Centre for Public Health, Queen's University Belfast, UK; M.J. López-Valladares, PhD, University Hospital Complex of Santiago de Compostela, Spain

Criteria

Inclusion criteria:

1. Presence of cataract with visual symptoms that justify the intervention, such as photophobia, difficulty in activities of daily living or driving.

2. 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.

3. Naive patients or without topical hypotensive treatment in the last 3 months.

4. Age: patients > 60 years.

5. Best corrected visual acuity (BCVA) between range > 0.4 and <0.7

6. Signature of the specific informed consent of the study.

Exclusion criteria:

1. 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

2. Corneal edema, corneal opacity or any other known corneal factor that may increase the risk of complications during surgery

3. Previous cataract surgery in the eye included in the study

4. Axial length <20 mm

5. Estimated IOL power> 30 diopters

6. Visual acuity <0.4 or> 0.7

7. Signs of zonular weakness: phacodonesis, iridodonesis, lens subluxation, asymmetry of anterior chamber depth

8. Pupillary dilation <5 mm

9. Advanced cataract