Pigment Dispersion SyndromeNCT01053416
Pigment Dispersion Syndrome: Natural History and Possible Protective Effect of a YAG Laser Iridotomy
A study testing Yag laser iridotomy in people with Pigment Dispersion Syndrome, run by University of Parma at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pigment Dispersion Syndrome
- What is being tested?
- Yag laser iridotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- Jan 1993to Dec 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Krukenberg spindle
- Slit-like mid peripheral iris defect
- Pigment in > 270° of AC angle
Who cannot join
- IOP > 18 mmHg
- PEX (full mydriasis)
- w/w field defect (Octopus G1 program)
Trial locations and contacts
1 site in 1 country.
About this study
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 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
Read the 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.
- Conditions
- Pigment Dispersion Syndrome
- Being tested
- Yag laser iridotomy
- Keywords
- glaucoma, pigmentary glaucoma, laser iridotomy
- Medical subject headings
- Glaucoma-Related Pigment Dispersion Syndrome, Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yag laser iridotomyProcedure or surgery
Also called iridectomy
the procedure will be performed by using a Yag laser. Single spot, 1 mJ power, beam aimed to an existing iris crypt
| Study group | Role | What they receive |
|---|---|---|
| observation | No intervention | Not described |
| Yag laser iridotomy | Experimental | the enrolled eyes will undergo an iridotomy performed by using a Yag-laser Receives: Procedure: Yag laser iridotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
> 5 mmHg IOP increase vs baseline (average 2 highest readings, 8 am - 6 pm phasing, 6 readings)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startJan 1993
- Primary completionApr 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pigment Dispersion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053416
- Sponsor's protocol ID
- PARMAPIGMO
- Status last verified
- Jan 2003
- First submitted
- 20 Jan 2010
- Last updated
- 22 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25188224
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01053416
- Acronym / sponsor ID
- PARMAPIGMO
- Conditions
- Pigment Dispersion Syndrome
- Keywords
- glaucoma, pigmentary glaucoma, laser iridotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- Jan 1993
- Primary completion
- Apr 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 21 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observation | No intervention | – |
| Yag laser iridotomy | Experimental | Procedure: Yag laser iridotomythe enrolled eyes will undergo an iridotomy performed by using a Yag-laser |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Krukenberg spindle
- Slit-like mid peripheral iris defect
- Pigment in > 270° of AC angle
Key exclusion criteria (3 listed)
- IOP > 18 mmHg
- PEX (full mydriasis)
- w/w field defect (Octopus G1 program)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yag laser iridotomyAlso: iridectomythe procedure will be performed by using a Yag laser. Single spot, 1 mJ power, beam aimed to an existing iris crypt | Procedure or surgery | Yag laser iridotomy |
Primary outcome
> 5 mmHg IOP increase vs baseline (average 2 highest readings, 8 am - 6 pm phasing, 6 readings)
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2010.
- Derived from this study: PubMed 25188224Gandolfi 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.
Related trials for Pigment Dispersion Syndrome
Recruiting
Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma
Glaucoma, Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yag laser iridotomy in people with Pigment Dispersion Syndrome, run by University of Parma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
> 5 mmHg IOP increase vs baseline (average 2 highest readings, 8 am - 6 pm phasing, 6 readings) (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01053416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2010.