Clinical Trials Directory

Trials / Completed

CompletedNCT01053416

Pigment Dispersion Syndrome: Natural History and Possible Protective Effect of a YAG Laser Iridotomy

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
72 (actual)
Sponsor
University of Parma · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREYag laser iridotomythe procedure will be performed by using a Yag laser. Single spot, 1 mJ power, beam aimed to an existing iris crypt

Timeline

Start date
1993-01-01
Primary completion
2003-04-01
Completion
2003-12-01
First posted
2010-01-21
Last updated
2010-01-22

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT01053416. Inclusion in this directory is not an endorsement.