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

This study has been completed.

Sponsor:

Information provided by:

University of Parma

ClinicalTrials.gov Identifier:

NCT01053416

First received: January 20, 2010

Last updated: January 21, 2010

Last verified: January 2003

History of Changes

Tracking Information
First Received Date ^ICMJE	January 20, 2010
Last Updated Date	January 21, 2010
Start Date ^ICMJE	January 1993
Primary Completion Date	April 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 20, 2010)	> 5 mmHg IOP increase vs baseline (average 2 highest readings, 8 am - 6 pm phasing, 6 readings) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01053416 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Pigment Dispersion Syndrome: Natural History and Possible Protective Effect of a YAG Laser Iridotomy
Official Title ^ICMJE	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
Brief Summary	STUDY AIMS 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
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Pigment Dispersion Syndrome
Intervention ^ICMJE	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
Study Arm (s)	No Intervention: observation Experimental: Yag laser iridotomy the enrolled eyes will undergo an iridotomy performed by using a Yag-laser Intervention: Procedure: Yag laser iridotomy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	72
Completion Date	December 2003
Primary Completion Date	April 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Krukenberg spindle Slit-like mid peripheral iris defect Pigment in > 270° of AC angle Exclusion Criteria: IOP > 18 mmHg PEX (full mydriasis) w/w field defect (Octopus G1 program)
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01053416
Other Study ID Numbers ^ICMJE	PARMAPIGMO
Has Data Monitoring Committee	No
Responsible Party	STEFANO A. GANDOLFI, PROFESSOR OF OPHTHALMOLOGY AND CHAIRMAN, UNIVERSITY OF PARMA
Study Sponsor ^ICMJE	University of Parma
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Parma
Verification Date	January 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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