Advanced GlaucomaPhase 1/2NCT00349414
Safety Study of Conventional Versus Micropulse Transscleral Cyclophotocoagulation in Treating End-Stage Glaucoma
A Phase 1/2 study testing Micropulse Transscleral Cyclophotocoagulation and Conventional Transscleral Cyclophotocoagulation in people with Advanced Glaucoma and Refractory Glaucoma, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The aim of this study is to compare the safety and efficacy of conventional and micropulse transscleral diode laser in the treatment of end-stage glaucoma. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Glaucoma, Refractory Glaucoma
- What is being tested?
- Micropulse Transscleral Cyclophotocoagulation and Conventional Transscleral Cyclophotocoagulation
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2006to Dec 2008
- Phase
- Phase 1/2
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- · More than 21 years old
- Advanced glaucoma refractory to maximum tolerated medical and surgical treatment
- Visual acuity worse than 6/60
- Poor candidates for additional filtration surgery
Who cannot join
- · Any eye surgery done within 2 months of enrolment
- Any ocular infection or inflammation
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital Singapore Department of Ophthalmology
Singapore, 119074
Anna Tan, MMEd
Grace Dizon, MD
About this study
Official title: A Comparison of the Safety and Efficacy of Conventional Versus Micropulse Transscleral Diode Laser Cyclophotocoagulation in Refractory Glaucoma
The aim of this study is to compare the safety and efficacy of conventional and micropulse transscleral diode laser in the treatment of end-stage glaucoma.
Read the detailed description
End-stage glaucoma is difficult to treat, and it may sometimes be unresponsive to surgery or medications. A common treatment is the conventional transscleral cyclophotocoagulaion, but it has various side effects. This study specifically aims to compare the intraocular pressure (IOP) lowering effects and the incidence of complications such as hypotony, phthisis, sympathetic ophthalmia, surface conjunctival burns, bulbar conjunctival swelling, decompensation of corneal grafts, hyphema and vitreous hemorrhage, in conventional and the newer micropulse transscleral cyclophotocoagulation.The hypothesis is that the micropulse transscleral cyclophotocoagulation will be as good or better than the conventional transscleral cyclophotocoagulation, with less complications.
- Conditions
- Advanced Glaucoma, Refractory Glaucoma
- Being tested
- Micropulse Transscleral Cyclophotocoagulation, Conventional Transscleral Cyclophotocoagulation
- Keywords
- Advanced glaucoma, Refractory glaucoma, Cyclophotocoagulation, Transscleral cyclophotocoagulation, Micropulse transscleral cyclophotocoagulation
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micropulse Transscleral CyclophotocoagulationProcedure or surgery
Conventional Transscleral CyclophotocoagulationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients in each group that had a 30% decrease of IOP from baseline after 6 months
Secondary outcomes (1)
Number of patients with complications, such as hypotony, phthisis, sympathetic ophthalmia, surface conjunctival burns, bulbar conjunctival swelling, decompensation of corneal grafts, hyphema and vitreous hemorrhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2006 (estimated)
- Study startJul 2006
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced GlaucomaStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Paul Chew, FRCSEd,MMed, Principal investigator, National University Hospital,Ophthalmology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349414
- Sponsor's protocol ID
- DSRB Reference Code: A/06/164
- Status last verified
- May 2008
- First submitted
- 6 Jul 2006
- Last updated
- 15 May 2008
- Results posted
- No
Publications
Berger JW. Thermal modelling of micropulsed diode laser retinal photocoagulation. Lasers Surg Med. 1997;20(4):409-15. doi: 10.1002/(sici)1096-9101(1997)20:43.0.co;2-u.
PubMed 9142680Ho CL, Wong EY, Chew PT. Effect of diode laser contact transscleral pars plana photocoagulation on intraocular pressure in glaucoma. Clin Exp Ophthalmol. 2002 Oct;30(5):343-7. doi: 10.1046/j.1442-9071.2002.00553.x.
PubMed 12213158
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Safety and Efficacy of Conventional Versus Micropulse Transscleral Diode Laser Cyclophotocoagulation in Refractory Glaucoma
- ClinicalTrials.gov ID
- NCT00349414
- Acronym / sponsor ID
- DSRB Reference Code: A/06/164
- Conditions
- Advanced Glaucoma, Refractory Glaucoma
- Keywords
- Advanced glaucoma, Refractory glaucoma, Cyclophotocoagulation, Transscleral cyclophotocoagulation, Micropulse transscleral cyclophotocoagulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Dec 2008 (estimated)
- First posted
- 7 Jul 2006 (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.
The aim of this study is to compare the safety and efficacy of conventional and micropulse transscleral diode laser in the treatment of end-stage glaucoma.
Detailed description
End-stage glaucoma is difficult to treat, and it may sometimes be unresponsive to surgery or medications. A common treatment is the conventional transscleral cyclophotocoagulaion, but it has various side effects. This study specifically aims to compare the intraocular pressure (IOP) lowering effects and the incidence of complications such as hypotony, phthisis, sympathetic ophthalmia, surface conjunctival burns, bulbar conjunctival swelling, decompensation of corneal grafts, hyphema and vitreous hemorrhage, in conventional and the newer micropulse transscleral cyclophotocoagulation.The hypothesis is that the micropulse transscleral cyclophotocoagulation will be as good or better than the conventional transscleral cyclophotocoagulation, with less complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- · More than 21 years old
Key exclusion criteria (3 listed)
- · Any eye surgery done within 2 months of enrolment
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 |
|---|---|---|
| Micropulse Transscleral Cyclophotocoagulation | Procedure or surgery | – |
| Conventional Transscleral Cyclophotocoagulation | Procedure or surgery | – |
Primary outcome
Number of patients in each group that had a 30% decrease of IOP from baseline after 6 months
1 secondary outcome
Number of patients with complications, such as hypotony, phthisis, sympathetic ophthalmia, surface conjunctival burns, bulbar conjunctival swelling, decompensation of corneal grafts, hyphema and vitreous hemorrhage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2008.
- Background: PubMed 9142680Berger JW. Thermal modelling of micropulsed diode laser retinal photocoagulation. Lasers Surg Med. 1997;20(4):409-15. doi: 10.1002/(sici)1096-9101(1997)20:43.0.co;2-u.
- Background: PubMed 12213158Ho CL, Wong EY, Chew PT. Effect of diode laser contact transscleral pars plana photocoagulation on intraocular pressure in glaucoma. Clin Exp Ophthalmol. 2002 Oct;30(5):343-7. doi: 10.1046/j.1442-9071.2002.00553.x.
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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.
Paul Chew, FRCSEd,MMed principal investigator
National University Hospital,Ophthalmology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Micropulse Transscleral Cyclophotocoagulation and Conventional Transscleral Cyclophotocoagulation in people with Advanced Glaucoma and Refractory Glaucoma, run by National University Hospital, Singapore at 1 site in Singapore.
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 4 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 15 May 2008. 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 Singapore. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Anna Tan, MMed (6772-5317, amwttan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients in each group that had a 30% decrease of IOP from baseline after 6 months. 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 NCT00349414, which also lists 2 linked publications.
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 15 May 2008.