Pigment Dispersion Syndrome: Natural History and Possible Protective Effect of a YAG Laser Iridotomy
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|ClinicalTrials.gov Identifier: NCT01053416|
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : January 22, 2010
- To determine the 10-year conversion rate from pigment dispersion syndrome (PDS) to pigmentary glaucoma (PG)
- To evaluate the possible protective effect of a Yag-laser iridotomy
|Condition or disease||Intervention/treatment||Phase|
|Pigment Dispersion Syndrome||Procedure: Yag laser iridotomy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||January 1993|
|Actual Primary Completion Date :||April 2003|
|Actual Study Completion Date :||December 2003|
|No Intervention: observation|
Experimental: Yag laser iridotomy
the enrolled eyes will undergo an iridotomy performed by using a Yag-laser
Procedure: Yag laser iridotomy
the procedure will be performed by using a Yag laser. Single spot, 1 mJ power, beam aimed to an existing iris crypt
Other Name: iridectomy
- > 5 mmHg IOP increase vs baseline (average 2 highest readings, 8 am - 6 pm phasing, 6 readings) [ Time Frame: 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053416
|Sezione Di Oftalmologia, Universita' Di Parma|
|Parma, Italy, 43100|