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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01053416
Enrollment
72
Registered
2010-01-21
Start date
1993-01-31
Completion date
2003-12-31
Last updated
2010-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pigment Dispersion Syndrome

Keywords

glaucoma, pigmentary glaucoma, laser iridotomy

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.

Interventions

PROCEDUREYag laser iridotomy

the procedure will be performed by using a Yag laser. Single spot, 1 mJ power, beam aimed to an existing iris crypt

Sponsors

University of Parma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026