Pigment Dispersion Syndrome: Natural History and Possible Protective Effect of a YAG Laser Iridotomy
NCT ID: NCT01053416
Last Updated: 2010-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
1993-01-31
2003-12-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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observation
No interventions assigned to this group
Yag laser iridotomy
the enrolled eyes will undergo an iridotomy performed by using a Yag-laser
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Slit-like mid peripheral iris defect
* Pigment in \> 270° of AC angle
Exclusion Criteria
* PEX (full mydriasis)
* w/w field defect (Octopus G1 program)
ALL
No
Sponsors
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University of Parma
OTHER
Responsible Party
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UNIVERSITY OF PARMA
Locations
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Sezione Di Oftalmologia, Universita' Di Parma
Parma, , Italy
Countries
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References
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Gandolfi SA, Ungaro N, Tardini MG, Ghirardini S, Carta A, Mora P. A 10-year follow-up to determine the effect of YAG laser iridotomy on the natural history of pigment dispersion syndrome: a randomized clinical trial. JAMA Ophthalmol. 2014 Dec;132(12):1433-8. doi: 10.1001/jamaophthalmol.2014.3291.
Other Identifiers
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PARMAPIGMO
Identifier Type: -
Identifier Source: org_study_id
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