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

Not Applicable

Completed

• Conditions: Pigment Dispersion Syndrome
• Interventions: Procedure: Yag laser iridotomy

• Registration Number: NCT01053416
• Lead Sponsor: University of Parma

Brief 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.

Study Timeline

• Study Start: 1993-01
• Status Verified: 2003-01
• Primary Completion: 2003-04
• Study Completion: 2003-12
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Last Update Submitted: 2010-01-21
• Last Update Posted: 2010-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yag laser iridotomy	Yag laser iridotomy	the enrolled eyes will undergo an iridotomy performed by using a Yag-laser

Primary Outcome Measures

Name	Time	Method
> 5 mmHg IOP increase vs baseline (average 2 highest readings, 8 am - 6 pm phasing, 6 readings)	10 years

Trial Locations

Locations (1)

Sezione Di Oftalmologia, Universita' Di Parma; 🇮🇹 Parma, Italy