search
Back to results

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

Primary Purpose

Pigment Dispersion Syndrome

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Yag laser iridotomy
Sponsored by
University of Parma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pigment Dispersion Syndrome focused on measuring glaucoma, pigmentary glaucoma, laser iridotomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Sezione Di Oftalmologia, Universita' Di Parma

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

observation

Yag laser iridotomy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 20, 2010
Last Updated
January 21, 2010
Sponsor
University of Parma
search

1. Study Identification

Unique Protocol Identification Number
NCT01053416
Brief Title
Pigment Dispersion Syndrome: Natural History and Possible Protective Effect of a YAG Laser Iridotomy
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 Type
Interventional

2. Study Status

Record Verification Date
January 2003
Overall Recruitment Status
Completed
Study Start Date
January 1993 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
December 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Parma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
STUDY AIMS To determine the 10-year conversion rate from pigment dispersion syndrome (PDS) to pigmentary glaucoma (PG) To evaluate the possible protective effect of a Yag-laser iridotomy
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pigment Dispersion Syndrome
Keywords
glaucoma, pigmentary glaucoma, laser iridotomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
observation
Arm Type
No Intervention
Arm Title
Yag laser iridotomy
Arm Type
Experimental
Arm Description
the enrolled eyes will undergo an iridotomy performed by using a Yag-laser
Intervention Type
Procedure
Intervention Name(s)
Yag laser iridotomy
Other Intervention Name(s)
iridectomy
Intervention Description
the procedure will be performed by using a Yag laser. Single spot, 1 mJ power, beam aimed to an existing iris crypt
Primary Outcome Measure Information:
Title
> 5 mmHg IOP increase vs baseline (average 2 highest readings, 8 am - 6 pm phasing, 6 readings)
Time Frame
10 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Sezione Di Oftalmologia, Universita' Di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25188224
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs