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OpenTrials
Completed

NCT Number: NCT01053416

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

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

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Key information

Conditions

Pigment Dispersion Syndrome Eye Diseases Glaucoma Glaucoma, Open-Angle Glaucoma-Related Pigment Dispersion Syndrome Ocular Hypertension

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sezione Di Oftalmologia, Universita' Di Parma

Parma, 43100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Yag laser iridotomy

Procedure

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

Other names: iridectomy

Primary outcomes

  1. > 5 mmHg IOP increase vs baseline (average 2 highest readings, 8 am - 6 pm phasing, 6 readings)

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Registry information

Official study 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

Important dates

Study start
1993
Primary completion
2003
Study completion
2003
First posted
Jan 21, 2010
Registry last updated
Jan 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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