Pigment Dispersion SyndromeNCT05231928
A Novel Argon Laser Iridoplasty for Pigment Dispersion Syndrome
A study testing Argon Laser Iridoplasty in people with Pigment Dispersion Syndrome and Pigmentary Glaucoma, run by Fayoum University at 1 site in Egypt.
Trial summary
Pigment dispersion syndrome is a rare condition where anomalous iris configuration leads to posterior iris bowing with subsequent friction with the lenticulozonular unit resulting in dispersion of pigment from the back surface of the iris into the anterior segment as well as thinning with resultant transillumination… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Pigment Dispersion Syndrome, Pigmentary Glaucoma
- What is being tested?
- Argon Laser Iridoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 Feb 2023
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pigment dispersion syndrome/glaucoma confirmed by either clinical signs or imaging with documented posterior iris bowing.
Who cannot join
- Active or history of Uveitis.
- Pupil size > 7mm in mesopic conditions.
- Previous Iris-based laser procedures e.g. Iridotomy, Iridoplasty
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Fayoum University Hospitals
Al Fayyum
Somaya Al Gohary, PhD, +200846300587, smg02@fayoum.edu.eg
Nader Shaaban, PhD, +200846300587, nsz00@fayoum.edu.eg
About this study
Official title: Efficacy of a Novel Argon Laser Iridoplasty for Management of Pigment Dispersion Syndrome Assessed by Anterior Segment Optical Coherence Tomography
Pigment dispersion syndrome is a rare condition where anomalous iris configuration leads to posterior iris bowing with subsequent friction with the lenticulozonular unit resulting in dispersion of pigment from the back surface of the iris into the anterior segment as well as thinning with resultant transillumination defects in the mid iris segment. The released pigment is deposited in various parts of the anterior segment resulting in a constellation of clinical signs:
Krukenberg Spindle: Back surface of the cornea Zentmayer ring: Back surface of the lens. Egger line: Anterior vitreous face. More importantly, pigment accumulated in the trabecular meshwork leading to visible hyperpigmentation of the trabeculum seen by gonioscopy. This leads to reduction of aqueous outflow which leads to ocular hypertension or even glaucoma which is known as pigment dispersion glaucoma which is considered one of refractory glaucomas.
Read more
Current practice in the management of pigment dispersion syndrome revolves around the management of glaucoma when it develops by IOP lowering medication, Laser trabeculoplasty or peripheral iridoplastyor glaucoma surgery as a last resort. The only prophylactic measure in practice that is aimed at preventing the progression from mere pigment dispersion to pigment dispersion glaucoma is the long term use of miotic eyedrops e.g. Pilocarpine which comes with both risks and side effects i.e. the risk of retinal breaks and detachment which is even higher in a cohort which is predominantly myope, the constriction of visual field and ocular surface complications.
In this interventional case series, the investigators assess the efficacy of a novel Argon Laser iridoplasty in the management of pigment dispersion through correcting the posterior iris bowing and hence halting the dispersion process so that glaucoma wouldn't develop in the first place instead of managing glaucoma after it sets in which proved refractory.
Read the detailed description
*Study design: Interventional, longitudinal, prospective, uncontrolled case series study
**Methods:
- Population: cases of pigment dispersion syndrome/glaucoma.
- Sample size:
Not determined since it is a case series with still active recruitment.
- A series of pigment dispersion syndrome and/or pigment dispersion glaucoma cases encountered in the ophthalmology outpatient clinic of Fayoum University Hospitals will be assessed clinically for confirmation of signs of pigment dispersion by slitlamp examination and gonioscopy. Intraocular pressure will be measured and monitored. Fundus examination with special attention to the optic disc will be done. Cases will be assessed prior to iridoplasty by anterior segment optical coherence tomography to document the anomalous iris configuration with subsequent serial anterior segment OCT at one week, one month and three months after iridoplasty as well as IOP measurement.
- The iridoplasty procedure will be performed as follows:
- Pilocarpine 2% topically is used to induce miosis.
- Topical ocular anesthetic is instilled.
- The Nidek Argon laser device together with a YAG capsolutomy or Abraham Iridotomy lens as auxilliary lenses are used.
- The site and parameters of argon laser applications on the anterior iris surface are tailored for each patient according to iris configuration and pupil diameter in mesopic conditions determined by anterior segment OCT.
- Topical Brimonidine 0.2% bid is used for one week after the procedure to guard against IOP spikes.
- Conditions
- Pigment Dispersion Syndrome, Pigmentary Glaucoma
- Being tested
- Argon Laser Iridoplasty
- Medical subject headings
- Glaucoma-Related Pigment Dispersion Syndrome, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argon Laser IridoplastyProcedure or surgery
Argon Laser is applied to the anterior iris surface at sites and with parameters tailored according to iris configuration, pupil size, iris colour.
The device used is Nidek Argon Laser device with YAG capsulotomy or Abraham Iridotomy lens as auxilliary lenses.
-Topical Pilocarpine 2% and ocular surface anesthetic are applied prior to the procedure and Brimonidine 0.2% bid is used fo a week after the procedure together with topical dexamethasone ophthalmic solution.
| Study group | Role | What they receive |
|---|---|---|
| Argon Laser Iridoplasty | Experimental | Argon Laser is applied to the anterior iris surface after pharmacological miosis and instillation of ocular surface anesthetic using YAG capsulotomy lens or Abraham Iridotomy lens as auxiliary lenses. Laser is applied at sites and with parameters that are tailored for each case according to exact iris configuration, iris colour and pupil diameter. Receives: Procedure: Argon Laser Iridoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
correction of posterior iris bowing
The posterior iris bowing is at the basis of pigment dispersion pathology and so the correction of this posterior bowing halts the disease process at its very roots.
Correction means either flattening or anterior bowing of iris (a change from negative bowing values to zero bowing or positive bowing values)
Measured: Baseline documentation of posterior bowing by anterior segment OCT followed by one week, one month, three months follow up by anterior segment OCT for changes in iris configuration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Dec 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigment Dispersion SyndromeStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional, longitudinal, prospective, uncontrolled case series
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Mohamed Ameen Ismail, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231928
- Sponsor's protocol ID
- R 211
- Status last verified
- Jul 2022
- First submitted
- 30 Jan 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Novel Argon Laser Iridoplasty for Management of Pigment Dispersion Syndrome Assessed by Anterior Segment Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT05231928
- Acronym / sponsor ID
- R 211
- Conditions
- Pigment Dispersion Syndrome, Pigmentary Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 9 Feb 2022 (actual)
- 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.
Pigment dispersion syndrome is a rare condition where anomalous iris configuration leads to posterior iris bowing with subsequent friction with the lenticulozonular unit resulting in dispersion of pigment from the back surface of the iris into the anterior segment as well as thinning with resultant transillumination defects in the mid iris segment. The released pigment is deposited in various parts of the anterior segment resulting in a constellation of clinical signs:
Krukenberg Spindle: Back surface of the cornea Zentmayer ring: Back surface of the lens. Egger line: Anterior vitreous face. More importantly, pigment accumulated in the trabecular meshwork leading to visible hyperpigmentation of the trabeculum seen by gonioscopy. This leads to reduction of aqueous outflow which leads to ocular hypertension or even glaucoma which is known as pigment dispersion glaucoma which is considered one of refractory glaucomas.
Current practice in the management of pigment dispersion syndrome revolves around the management of glaucoma when it develops by IOP lowering medication, Laser trabeculoplasty or peripheral iridoplastyor glaucoma surgery as a last resort. The only prophylactic measure in practice that is aimed at preventing the progression from mere pigment dispersion to pigment dispersion glaucoma is the long term use of miotic eyedrops e.g. Pilocarpine which comes with both risks and side effects i.e. the risk of retinal breaks and detachment which is even higher in a cohort which is predominantly myope, the constriction of visual field and ocular surface complications.
In this interventional case series, the investigators assess the efficacy of a novel Argon Laser iridoplasty in the management of pigment dispersion through correcting the posterior iris bowing and hence halting the dispersion process so that glaucoma wouldn't develop in the first place instead of managing glaucoma after it sets in which proved refractory.
Detailed description
*Study design: Interventional, longitudinal, prospective, uncontrolled case series study
**Methods:
- Population: cases of pigment dispersion syndrome/glaucoma.
- Sample size:
Not determined since it is a case series with still active recruitment.
- A series of pigment dispersion syndrome and/or pigment dispersion glaucoma cases encountered in the ophthalmology outpatient clinic of Fayoum University Hospitals will be assessed clinically for confirmation of signs of pigment dispersion by slitlamp examination and gonioscopy. Intraocular pressure will be measured and monitored. Fundus examination with special attention to the optic disc will be done. Cases will be assessed prior to iridoplasty by anterior segment optical coherence tomography to document the anomalous iris configuration with subsequent serial anterior segment OCT at one week, one month and three months after iridoplasty as well as IOP measurement.
- The iridoplasty procedure will be performed as follows:
- Pilocarpine 2% topically is used to induce miosis.
- Topical ocular anesthetic is instilled.
- The Nidek Argon laser device together with a YAG capsolutomy or Abraham Iridotomy lens as auxilliary lenses are used.
- The site and parameters of argon laser applications on the anterior iris surface are tailored for each patient according to iris configuration and pupil diameter in mesopic conditions determined by anterior segment OCT.
- Topical Brimonidine 0.2% bid is used for one week after the procedure to guard against IOP spikes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional, longitudinal, prospective, uncontrolled case series
| Arm | Type | Receives |
|---|---|---|
| Argon Laser Iridoplasty | Experimental | Procedure: Argon Laser IridoplastyArgon Laser is applied to the anterior iris surface after pharmacological miosis and instillation of ocular surface anesthetic using YAG capsulotomy lens or Abraham Iridotomy lens as auxiliary lenses. Laser is applied at sites and with parameters that are tailored for each case according to exact iris configuration, iris colour and pupil diameter. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pigment dispersion syndrome/glaucoma confirmed by either clinical signs or imaging with documented posterior iris bowing.
Key exclusion criteria (3 listed)
- Active or history of Uveitis.
- Pupil size > 7mm in mesopic conditions.
- Previous Iris-based laser procedures e.g. Iridotomy, Iridoplasty
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 |
|---|---|---|
| Argon Laser IridoplastyArgon Laser is applied to the anterior iris surface at sites and with parameters tailored according to iris configuration, pupil size, iris colour. The device used is Nidek Argon Laser device with YAG capsulotomy or Abraham Iridotomy lens as auxilliary lenses. -Topical Pilocarpine 2% and ocular surface anesthetic are applied prior to the procedure and Brimonidine 0.2% bid is used fo a week after the procedure together with topical dexamethasone ophthalmic solution. | Procedure or surgery | Argon Laser Iridoplasty |
Primary outcome
correction of posterior iris bowing
Time frame: Baseline documentation of posterior bowing by anterior segment OCT followed by one week, one month, three months follow up by anterior segment OCT for changes in iris configuration.
The posterior iris bowing is at the basis of pigment dispersion pathology and so the correction of this posterior bowing halts the disease process at its very roots. Correction means either flattening or anterior bowing of iris (a change from negative bowing values to zero bowing or positive bowing values)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Argon Laser Iridoplasty in people with Pigment Dispersion Syndrome and Pigmentary Glaucoma, run by Fayoum University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 26 Jul 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Ameen Ismail, MBBCh (00201067964547, am178@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correction of posterior iris bowing (time frame: Baseline documentation of posterior bowing by anterior segment OCT followed by one week, one month, three months follow up by anterior segment OCT for changes in iris configuration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2022.