Pigment Dispersion Syndrome Clinical Trial
Official title:
10-year Follow up of Patients With Pigment Dispersion Syndrome: Risk Factors for Conversion to Pigmentary Glaucoma and Potential Protective Effect of a Yag-laser Iridotomy in High Risk Eye
STUDY AIMS
1. To determine the 10-year conversion rate from pigment dispersion syndrome (PDS) to
pigmentary glaucoma (PG)
2. To evaluate the possible protective effect of a Yag-laser iridotomy
1154 workers in the Parma area will be screened for eligibility to long-term use of
video-monitors. Those referred to the Glaucoma Clinic for suspected PDS will be enrolled in
the study.
In a prospective study on the natural history of PDS and PG, Richter et al. (Arch Ophtal
104:211-5, 1986) found an association between "active pigment dispersion" and elevated IOP.
Therefore, in order to evaluate the "stability" of the pigment, a phenylephrine test will be
performed following the method reported by Epstein et al (1978) AJO 85:43-50. The test will
be performed by one investigator (SAG)and was considered positive if > "grade 1+" (i.e. at
least 10 particles in a single light beam). Eyes showing a positive test will be considered
as "high-risk" for conversion to PG.
Yag laser iridotomy will be performed in patients showing both eyes at high risk. One eye
only (randomly chosen) will be treated. the fellow eye will be left untreated and considered
as internal control.
Low risk eyes will be followed without any intervention.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
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