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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053416
• Other study ID #: PARMAPIGMO
• Status: Completed
• Phase: N/A
• First received: January 20, 2010
• Last updated: January 21, 2010
• Start date: January 1993
• Est. completion date: December 2003

Study information

• Verified date: January 2003
• Source: University of Parma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2003
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Pigment Dispersion Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Italy	Sezione Di Oftalmologia, Universita' Di Parma	Parma

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	> 5 mmHg IOP increase vs baseline (average 2 highest readings, 8 am - 6 pm phasing, 6 readings)		10 years	No