GlaucomaPhase 4IridoplastyNCT00485238
ALPI vs Medical Therapy Effects on Optic Nerve Structure & Function
A Phase 4 study testing Argon laser Iridoplasty and Intravenous acetazolamide in people with Glaucoma, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The aim is to determine which approach, immediate argon laser peripheral iridoplasty or conventional systemic medical treatment efficiently breaks acute angle closure attack without consequent visual morbidities. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Argon laser Iridoplasty and Intravenous acetazolamide
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2007to Dec 2008
- Phase
- Phase 4
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 21 years with ability to give informed consent and cooperate for a slit lamp laser procedure
- Subjects at their first presentation of acute primary angle closure attack.
- Intraocular pressure levels of 40 mm Hg or higher by applanation tonometry or tonopen
- Pupillary block as the main mechanism of angle closure
- No previous treatment
Who cannot join
- Age less than 21 years
- Angle closure due to non-pupil block mechanism (e.g. plateau iris, pseudoplateau, phacomorphic, malignant glaucoma) or other secondary causes (subluxed lens, neovascular, uveitic, traumatic, post-operative)
- Angle closure patients whose IOP's are not lowered by 20% or more, and are unresponsive to maximum medical IOP-lowering agents after one hour of initiating treatment and needing other intervention/s to lower IOP(e.g. iridoplasty, surgery).
- Corneal opacities or abnormalities obstructing laser application
- Use of contact lens
- Single-eyed patients
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
5 Lower Kent Ridge Road, Singapore, 119074
Paul TK Chew, A/Prof
About this study
Official title: EFFECTS OF IMMEDIATE ARGON LASER PERIPHERAL IRIDOPLASTY Versus CONVENTIONAL SYSTEMIC MEDICAL THERAPY ON OPTIC NERVE HEAD STRUCTURE AND FUNCTION OF ACUTE PRIMARY ANGLE CLOSURE EYES
The aim is to determine which approach, immediate argon laser peripheral iridoplasty or conventional systemic medical treatment efficiently breaks acute angle closure attack without consequent visual morbidities. The specific objectives are to see whether sudden intraocular pressure(IOP) lowering brought about by laser iridoplasty or medical treatment affects optic nerve head structure and function and identify if immediate decompression is associated with greater incidence of ocular problems like corneal endothelial compromise, optic disc edema, macular edema, decompression retinopathy, cataract formation, progression to chronic angle closure.
Read the detailed description
Primary Angle Closure Glaucoma (PACG) continues to be a major concern in Asia. It is a major cause of visual morbidity in the region1 being the most prevalent type of glaucoma especially in Chinese and Mongoloid descent.2,3 During the acute stage of the disease, prompt institution of measures to break the attack is necessary. Two recognized approaches are utilized in practice in lowering intraocular pressure and preparing for the definitive treatment of laser peripheral iridotomy. These are conventional topical and systemic medical therapy and immediate peripheral iridoplasty using either argon or diode lasers.
In the study of Lim, Tan, Chew, Seah et al., laser iridoplasty was noted to have a useful role in the management of medically unresponsive acute angle closure, particularly in those cases where laser peripheral iridotomy (PI) could not be successfully performed4 . Randomized controlled trials of Lam, Lai, Tham et al. comparing immediate laser peripheral iridoplasty plus topical medications and topical and systemic medical treatment found no significant difference in the eventual mean IOP and requirement for glaucoma medications 5 . However, significant difference in efficacy was observed between the two treatment arms within the first two hours of treatment with argon laser peripheral iridoplasty and topical medications lowering IOP faster than conventional medications6. In all the trials cited, there was no mention of sudden IOP lowering effects of either argon laser iridoplasty or conventional medications on the optic nerve head and visual field status, as well as its effect on other ocular structures like the cornea, lens and retina . In our literature search, two papers studied the optic nerve head structure and function in angle closure glaucoma, but not in the immediate period of sudden IOP lowering. Ang, Aung, Chua, Yip and Chew made a comparative assessment of the visual field loss between symptomatic and asymptomatic PACG, with 50% of asymptomatic PACG subjects presenting with end stage visual field loss in contrast to just 7% of symptomatic PACG.7 Lai, Tham, Lam et al. compared the retinal nerve fiber layer measurements of attack eyes and their fellow eyes after a single unilateral attack of acute primary angle closure (APAC) using scanning laser polarimetry six months after the acute attack8. Retinal nerve fiber layer damage was documented in eyes where the duration of the APAC attack lasted more than 48 hours8. Decompression retinopathy following laser peripheral iridoplasty for acute primary angle closure was reported in two cases reported by Lai, Lee, Leung and Chung.9 In order to compare the efficiency of laser peripheral iridoplasty and medical treatment, as well as to identify any morbidity that may come from sudden decompression of the eye, we undertake this randomized controlled trial.
- Conditions
- Glaucoma
- Being tested
- Argon laser Iridoplasty, Intravenous acetazolamide
- Keywords
- glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argon laser IridoplastyProcedure or surgery
Intravenous acetazolamideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
optic nerve head stereometric analysis HRT3 and Stratus OCT,optic nerve head and RNFL & macula thickness average. AGIS scores of HVF is the measure of functional status.
Measured: 1 year
Secondary outcomes (1)
amount and rate of IOP-lowering,gonioscopy and ASOCT changes, change in LOCS grading for cataract, corneal decompensation & edema,macular,retinal edema by Stratus OCT.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2007 (estimated)
- Study startFeb 2007
- Study completionDec 2008 (estimated)
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Paul TK Chew, A/Prof, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485238
- Sponsor's protocol ID
- DSRB A/06/177
- Acronym
- Iridoplasty
- Status last verified
- May 2008
- First submitted
- 11 Jun 2007
- Last updated
- 15 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Lai JS, Tham CC, Chua JK, Poon AS, Lam DS. Laser peripheral iridoplasty as initial treatment of acute attack of primary angle-closure: a long-term follow-up study. J Glaucoma. 2002 Dec;11(6):484-7. doi: 10.1097/00061198-200212000-00005.
PubMed 12483091
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
- EFFECTS OF IMMEDIATE ARGON LASER PERIPHERAL IRIDOPLASTY Versus CONVENTIONAL SYSTEMIC MEDICAL THERAPY ON OPTIC NERVE HEAD STRUCTURE AND FUNCTION OF ACUTE PRIMARY ANGLE CLOSURE EYES
- ClinicalTrials.gov ID
- NCT00485238
- Acronym / sponsor ID
- Iridoplasty / DSRB A/06/177
- Conditions
- Glaucoma
- Keywords
- glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Dec 2008 (estimated)
- First posted
- 12 Jun 2007 (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 is to determine which approach, immediate argon laser peripheral iridoplasty or conventional systemic medical treatment efficiently breaks acute angle closure attack without consequent visual morbidities. The specific objectives are to see whether sudden intraocular pressure(IOP) lowering brought about by laser iridoplasty or medical treatment affects optic nerve head structure and function and identify if immediate decompression is associated with greater incidence of ocular problems like corneal endothelial compromise, optic disc edema, macular edema, decompression retinopathy, cataract formation, progression to chronic angle closure.
Detailed description
Primary Angle Closure Glaucoma (PACG) continues to be a major concern in Asia. It is a major cause of visual morbidity in the region1 being the most prevalent type of glaucoma especially in Chinese and Mongoloid descent.2,3 During the acute stage of the disease, prompt institution of measures to break the attack is necessary. Two recognized approaches are utilized in practice in lowering intraocular pressure and preparing for the definitive treatment of laser peripheral iridotomy. These are conventional topical and systemic medical therapy and immediate peripheral iridoplasty using either argon or diode lasers.
In the study of Lim, Tan, Chew, Seah et al., laser iridoplasty was noted to have a useful role in the management of medically unresponsive acute angle closure, particularly in those cases where laser peripheral iridotomy (PI) could not be successfully performed4 . Randomized controlled trials of Lam, Lai, Tham et al. comparing immediate laser peripheral iridoplasty plus topical medications and topical and systemic medical treatment found no significant difference in the eventual mean IOP and requirement for glaucoma medications 5 . However, significant difference in efficacy was observed between the two treatment arms within the first two hours of treatment with argon laser peripheral iridoplasty and topical medications lowering IOP faster than conventional medications6. In all the trials cited, there was no mention of sudden IOP lowering effects of either argon laser iridoplasty or conventional medications on the optic nerve head and visual field status, as well as its effect on other ocular structures like the cornea, lens and retina . In our literature search, two papers studied the optic nerve head structure and function in angle closure glaucoma, but not in the immediate period of sudden IOP lowering. Ang, Aung, Chua, Yip and Chew made a comparative assessment of the visual field loss between symptomatic and asymptomatic PACG, with 50% of asymptomatic PACG subjects presenting with end stage visual field loss in contrast to just 7% of symptomatic PACG.7 Lai, Tham, Lam et al. compared the retinal nerve fiber layer measurements of attack eyes and their fellow eyes after a single unilateral attack of acute primary angle closure (APAC) using scanning laser polarimetry six months after the acute attack8. Retinal nerve fiber layer damage was documented in eyes where the duration of the APAC attack lasted more than 48 hours8. Decompression retinopathy following laser peripheral iridoplasty for acute primary angle closure was reported in two cases reported by Lai, Lee, Leung and Chung.9 In order to compare the efficiency of laser peripheral iridoplasty and medical treatment, as well as to identify any morbidity that may come from sudden decompression of the eye, we undertake this randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age more than 21 years with ability to give informed consent and cooperate for a slit lamp laser procedure
- Subjects at their first presentation of acute primary angle closure attack.
- Intraocular pressure levels of 40 mm Hg or higher by applanation tonometry or tonopen
- Pupillary block as the main mechanism of angle closure
- No previous treatment
Key exclusion criteria (6 listed)
- Age less than 21 years
- Angle closure due to non-pupil block mechanism (e.g. plateau iris, pseudoplateau, phacomorphic, malignant glaucoma) or other secondary causes (subluxed lens, neovascular, uveitic, traumatic, post-operative)
- Angle closure patients whose IOP's are not lowered by 20% or more, and are unresponsive to maximum medical IOP-lowering agents after one hour of initiating treatment and needing other intervention/s to lower IOP(e.g. iridoplasty, surgery).
- Corneal opacities or abnormalities obstructing laser application
- Use of contact lens
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 Iridoplasty | Procedure or surgery | – |
| Intravenous acetazolamide | Drug | – |
Primary outcome
optic nerve head stereometric analysis HRT3 and Stratus OCT,optic nerve head and RNFL & macula thickness average. AGIS scores of HVF is the measure of functional status.
Time frame: 1 year
1 secondary outcome
amount and rate of IOP-lowering,gonioscopy and ASOCT changes, change in LOCS grading for cataract, corneal decompensation & edema,macular,retinal edema by Stratus OCT.
Time frame: 1 year
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 12483091Lai JS, Tham CC, Chua JK, Poon AS, Lam DS. Laser peripheral iridoplasty as initial treatment of acute attack of primary angle-closure: a long-term follow-up study. J Glaucoma. 2002 Dec;11(6):484-7. doi: 10.1097/00061198-200212000-00005.
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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 TK Chew, A/Prof principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Argon laser Iridoplasty and Intravenous acetazolamide in people with 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 5 inclusion and 6 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Paul TK Chew, A/Prof (67725317, ophchewp@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
optic nerve head stereometric analysis HRT3 and Stratus OCT,optic nerve head and RNFL & macula thickness average. AGIS scores of HVF is the measure of functional status. (time frame: 1 year). 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 NCT00485238, 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 15 May 2008.