The International Collaborative Exfoliation Syndrome Treatment Study

• Status: Unknown status
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose: To determine the efficacy of treatment with latanoprost in combination with pilocarpine versus timolol or timolol/dorzolamide fixed combination (Timoptic or Cosopt) in eyes with XFS and elevated intraocular pressure (IOP).

Methods: This is a randomized, open-label study to test the hypothesis that improving both pressure-dependent and pressure-independent aqueous outflow and minimizing iridolenticular friction will interfere with the progression of XFS, allow improvement in trabecular function, and be more effective over time than simply reducing aqueous formation. Randomization was performed across the centers, per patient rather than per eye to avoid any crossover effect caused by aqueous suppressants. Group I was treated with latanoprost and pilocarpine, both in the evening, and Group II with Timolol or Cosopt b.i.d. Only one eye per patient was randomized. Patients were followed for 2 years with assessment of IOP, visual field progression, tonographic outflow coefficient and trabecular pigmentation at the 6:00 and 12:00 position.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The New York Eye & Ear Infirmary
• Collaborator: Pfizer
• Treatments: Latanoprost; Pilocarpine; Timolol

Criteria

Inclusion Criteria:

1. Exfoliation syndrome in one or both eyes. Exfoliation material must be present on the anterior lens surface for diagnosis.

2. Untreated IOP greater than or equal to 22 mmHg in one or both eyes with or without mild to moderate glaucomatous damage and who, in the judgment of the investigator, can be safely washed off from current medical therapy.

3. Age 50-80 years

4. Open angles by gonioscopy

Exclusion Criteria:

1. Age over 80 years

2. Best corrected visual acuity less than 20/30

3. Untreated IOP greater than 35 mmHg

4. Currently taking systemic beta-blockers

5. Glaucomatous damage sufficiently severe to prevent washout in the opinion of the examiner or visual field defect within 10 degrees of fixation

6. Glaucoma other than exfoliation syndrome

7. Absence of exfoliation material on the lens surface in the eye to be treated

8. Known allergy or sensitivity to any of the study medications

9. Ocular pathology that may interfere with the ability to obtain tonography, visual fields, or accurate IOP readings

10. Angle-closure glaucoma

11. Diabetic retinopathy

12. Previous intraocular or laser surgery.

13. Unwilling or unable to give consent

14. Pregnant or lactating women