NCT00349414

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2006

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 15, 2008

Status Verified

May 1, 2008

First QC Date

July 6, 2006

Last Update Submit

May 13, 2008

Conditions

Advanced GlaucomaRefractory Glaucoma

Keywords

Advanced glaucomaRefractory glaucomaCyclophotocoagulationTransscleral cyclophotocoagulationMicropulse transscleral cyclophotocoagulation

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Micropulse Transscleral CyclophotocoagulationPROCEDURE
Conventional Transscleral CyclophotocoagulationPROCEDURE

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • · 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

You may not qualify if:

  • · Any eye surgery done within 2 months of enrolment
  • Any ocular infection or inflammation
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital Singapore Department of Ophthalmology

Singapore, 119074, Singapore

RECRUITING

Related Publications (2)

  • 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.

    PMID: 9142680BACKGROUND

  • Ho 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.

    PMID: 12213158BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Paul Chew, FRCSEd,MMed

    National University Hospital,Ophthalmology Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Tan, MMed

CONTACT

6772-5317amwttan@yahoo.com

Grace Dizon, MD

CONTACT

6772-5317gengmd@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 7, 2006

Study Start

July 1, 2006

Study Completion

December 1, 2008

Last Updated

May 15, 2008

Record last verified: 2008-05

Locations

SG(1)