ALPI vs Medical Therapy Effects on Optic Nerve Structure & Function (Iridoplasty)
Primary Purpose
Glaucoma
Status
Unknown status
Phase
Phase 4
Locations
Singapore
Study Type
Interventional
Intervention
Argon laser Iridoplasty
Intravenous acetazolamide
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring glaucoma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- National University HospitalRecruiting
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00485238
First Posted
June 11, 2007
Last Updated
May 13, 2008
Sponsor
National University Hospital, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT00485238
Brief Title
ALPI vs Medical Therapy Effects on Optic Nerve Structure & Function
Acronym
Iridoplasty
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National University Hospital, Singapore
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Argon laser Iridoplasty
Intervention Type
Drug
Intervention Name(s)
Intravenous acetazolamide
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul TK Chew, A/Prof
Phone
67725317
Email
ophchewp@nus.edu.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Cecilia D. Aquino, M.D.
Phone
67725317
Email
cel_aq@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul TK Chew, A/Prof
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
5 Lower Kent Ridge Road, Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul TK Chew, A/Prof
12. IPD Sharing Statement
Citations:
PubMed Identifier
12483091
Citation
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.
Results Reference
background
Learn more about this trial
ALPI vs Medical Therapy Effects on Optic Nerve Structure & Function
We'll reach out to this number within 24 hrs