Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00485238
Status:
UNKNOWN
Last Update Posted:
2008-05-15
First Post:
2007-06-11
Brief Title:
ALPI vs Medical Therapy Effects on Optic Nerve Structure Function
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2008-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Iridoplasty
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 pressureIOP 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 descent23 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 PACG7 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 Chung9 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
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 PACG7 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 Chung9 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None