At a glance
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Randomised Controlled Trial to Evaluate the Efficacy and Safety of Lens Extraction in Patients With Pseudoexfoliation Glaucoma: a Feasibility and Pilot Study
In Brief
A clinical study evaluating PHACOEMULSIFICATION and MEDICAL GLAUCOMA TREATMENT for Pseudoexfoliation Glaucoma and Intraocular Pressure. Completed, enrolled 12 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Standard phacoemulsification with intraocular lens implant will be perform within 60 days after allocation. If IOP target is not achieve, patients will be treated as in "medical treatment group"
The escalation of topical hypotensive medications will be carried out with the following sequence: 1. single topical medication; 2. double topical therapy; 3. triple topical therapy. Beginning, with the exception of individual contraindications, with prostaglandin analogs, followed by topical beta-blockers, carbonic anhydrase inhibitors and finally alpha-agonists.Target IOP will be used in both groups to inform the need of escalation of therapy; in patients with ocular hypertension the target IOP will be 21 mmHg. In patients with mild glaucoma target IOP will be 18 mmHg, and in patients with moderate glaucoma the target IOP will be 15 mmHg.