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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01053416
Other study ID # PARMAPIGMO
Secondary ID
Status Completed
Phase N/A
First received January 20, 2010
Last updated January 21, 2010
Start date January 1993
Est. completion date December 2003

Study information

Verified date January 2003
Source University of Parma
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date December 2003
Est. primary completion date April 2003
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention


Intervention

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

Locations

Country Name City State
Italy Sezione Di Oftalmologia, Universita' Di Parma Parma

Sponsors (1)

Lead Sponsor Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary > 5 mmHg IOP increase vs baseline (average 2 highest readings, 8 am - 6 pm phasing, 6 readings) 10 years No
See also
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Completed NCT00005919 - Cause of Pigment Dispersion Syndrome N/A
Recruiting NCT05231928 - A Novel Argon Laser Iridoplasty for Pigment Dispersion Syndrome N/A
Completed NCT02165631 - The Diurnal and Nocturnal Effect of Simbrinza and Timolol on Intraocular Pressure and Ocular Perfusion Pressure N/A