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Efficacy and Safety of Lens Extraction in Patients With Pseudoexfoliation Glaucoma

NCT03494465 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-07-20

No results posted yet for this study

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.

Conditions

  • Pseudoexfoliation Glaucoma
  • Intraocular Pressure

Interventions

PROCEDURE

PHACOEMULSIFICATION

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"

DRUG

MEDICAL GLAUCOMA TREATMENT

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.

Sponsors & Collaborators

  • Xerencia de Xestión Integrada de Ferrol

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2020-02-28
Completion
2021-03-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03494465 on ClinicalTrials.gov