Safety Study of Conventional Versus Micropulse Transscleral Cyclophotocoagulation in Treating End-Stage Glaucoma

NCT ID: NCT00349414

Last Updated: 2008-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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End-stage glaucoma is difficult to treat, and it may sometimes be unresponsive to surgery or medications. A common treatment is the conventional transscleral cyclophotocoagulaion, but it has various side effects. This study specifically aims to compare the intraocular pressure (IOP) lowering effects and the incidence of complications such as hypotony, phthisis, sympathetic ophthalmia, surface conjunctival burns, bulbar conjunctival swelling, decompensation of corneal grafts, hyphema and vitreous hemorrhage, in conventional and the newer micropulse transscleral cyclophotocoagulation.The hypothesis is that the micropulse transscleral cyclophotocoagulation will be as good or better than the conventional transscleral cyclophotocoagulation, with less complications.

Conditions

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Advanced Glaucoma Refractory Glaucoma

Keywords

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Advanced glaucoma Refractory glaucoma Cyclophotocoagulation Transscleral cyclophotocoagulation Micropulse transscleral cyclophotocoagulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Micropulse Transscleral Cyclophotocoagulation

Intervention Type PROCEDURE

Conventional Transscleral Cyclophotocoagulation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* · 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

Exclusion Criteria

* · Any eye surgery done within 2 months of enrolment

* Any ocular infection or inflammation
* Unable to give informed consent
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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National University Hospital

Principal Investigators

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Paul Chew, FRCSEd,MMed

Role: PRINCIPAL_INVESTIGATOR

National University Hospital,Ophthalmology Department

Locations

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National University Hospital Singapore Department of Ophthalmology

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Anna Tan, MMed

Role: CONTACT

Phone: 6772-5317

Email: [email protected]

Grace Dizon, MD

Role: CONTACT

Phone: 6772-5317

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 9142680 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12213158 (View on PubMed)

Other Identifiers

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DSRB Reference Code: A/06/164

Identifier Type: -

Identifier Source: org_study_id