ALPI vs Medical Therapy Effects on Optic Nerve Structure & Function

NCT00485238 | Unknown Phase 4

• 1 other identifier: DSRB A/06/177
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

glaucoma

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  1 year

Interventions

Argon laser Iridoplasty PROCEDURE

Intravenous acetazolamide DRUG

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

5 Lower Kent Ridge Road, Singapore, 119074, Singapore

RECRUITING

Related Publications (1)

• 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.

  PMID: 12483091 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Paul TK Chew, A/Prof

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul TK Chew, A/Prof

CONTACT

67725317; ophchewp@nus.edu.sg

Maria Cecilia D. Aquino, M.D.

CONTACT

67725317; cel_aq@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 12, 2007
• Study Start: February 1, 2007
• Study Completion: December 1, 2008
• Last Updated: May 15, 2008

Record last verified: 2008-05

Locations

SG (1)