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

University of Parma

Status: Completed

Conditions: Pigment Dispersion Syndrome

Treatments: Procedure: Yag laser iridotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01053416

PARMAPIGMO

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

observation

No Intervention group

Yag laser iridotomy

Experimental group

Description:

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

Treatment:

Procedure: Yag laser iridotomy