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

Sponsor
University of Parma (Other)
Overall Status
Completed
CT.gov ID
NCT01053416
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
131
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Yag laser iridotomy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
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
Study Start Date :
Jan 1, 1993
Actual Primary Completion Date :
Apr 1, 2003
Actual Study Completion Date :
Dec 1, 2003

Arms and Interventions

Arm Intervention/Treatment
No Intervention: observation
Experimental: Yag laser iridotomy

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

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
Other Names:
  • iridectomy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. > 5 mmHg IOP increase vs baseline (average 2 highest readings, 8 am - 6 pm phasing, 6 readings) [10 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sezione Di Oftalmologia, Universita' Di Parma Parma Italy 43100

    Sponsors and Collaborators

    • University of Parma

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01053416
    Other Study ID Numbers:
    • PARMAPIGMO
    First Posted:
    Jan 21, 2010
    Last Update Posted:
    Jan 22, 2010
    Last Verified:
    Jan 1, 2003
    Keywords provided by , ,
    glaucoma
    pigmentary glaucoma
    laser iridotomy
    Additional relevant MeSH terms:
    Glaucoma, Open-Angle
    Syndrome

    Study Results

    No Results Posted as of Jan 22, 2010