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

January 20, 2010
January 21, 2010
January 1993
April 2003   (final data collection date for primary outcome measure)
> 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 ]
Same as current
Complete list of historical versions of study NCT01053416 on ClinicalTrials.gov Archive Site
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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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Pigment Dispersion Syndrome
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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
December 2003
April 2003   (final data collection date for primary outcome measure)

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)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01053416
PARMAPIGMO
No
STEFANO A. GANDOLFI, PROFESSOR OF OPHTHALMOLOGY AND CHAIRMAN, UNIVERSITY OF PARMA
University of Parma
Not Provided
Not Provided
University of Parma
January 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP