The International Collaborative Exfoliation Syndrome Treatment Study
Information source: The New York Eye & Ear Infirmary
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Exfoliation Syndrome; Glaucoma; Ocular Hypertension
Intervention: Latanoprost with Pilocarpine vs Timolol or Cosopt (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: The New York Eye & Ear Infirmary Official(s) and/or principal investigator(s):
Robert Ritch, MD, Principal Investigator, Affiliation: New York Eye and Ear Infirmary
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.
Clinical Details
Official title: The International Collaborative Exfoliation Syndrome Treatment Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Latanoprost combined with pilocarpine (L-PILO) should be as effective as timolol or Cosopt in lowering IOP
Detailed description:
Purpose: To compare the effect of treatment with latanoprost plus pilocarpine vs timolol or
fixed combination timolol/dorzolamide (T/D) in eyes with exfoliation syndrome (XFS) and
elevated IOP.
Methods: A randomized, prospective, international, 12-center, two-year, open-label clinical
trial was conducted. XFS patients aged 50-80 years with untreated IOP ≥22 mmHg and open
angles with or without mild to moderate glaucomatous damage were included. One eligible eye
per patient was randomly assigned to latanoprost and pilocarpine qhs to increase aqueous
outflow and inhibit pupillary movement (group I), or to decrease aqueous production with
timolol or T/D bid as needed for IOP control (group II). IOP, tonographic outflow facility,
and trabecular pigmentation were measured every 6 months.
Results: 277 (146 male) patients (mean age 69. 1±6. 8 yr, range 50-80 yr)` were enrolled
between October 2000 and July 2003. XFS was unilateral in 118 (42. 6%) and bilateral in 159
(57. 4%) patients. Baseline TM pigmentation at the 6: 00 angle was significantly associated
with IOP (p=0. 01). IOP reduction was 1. 3 mmHg greater in Group I (n=145) than in Group II
(n=132) (p=0. 0003). Mean increase in outflow facility in Group I was 0. 005 µl/mmHg/min vs 0
μl/mmHg/min in Group II (p<0. 001). TM pigmentation at the 6: 00 position at 24 months
decreased from baseline more frequently in Group I than in Group II [34(26%) vs 20(16%)] and
increased from baseline more frequently in Group II than in Group I [31(25%) vs 24(18%)].
Conclusions: Subjects in Group I had lower IOP, improved outflow facility and decreased TM
pigmentation. Initial therapy to increase aqueous outflow and interfere with dispersion of
exfoliation material and iris pigment by inhibiting pupillary movement is preferable to
reducing aqueous secretion, which may be deleterious as primary treatment in this disorder.
Eligibility
Minimum age: 50 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
New York Eye and Ear Infirmary, New York, New York 10003, United States
Additional Information
Starting date: August 2000
Last updated: December 5, 2008
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