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

N

National University Health System (NUHS)

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Advanced Glaucoma
Refractory Glaucoma

Treatments

Procedure: Micropulse Transscleral Cyclophotocoagulation
Procedure: Conventional Transscleral Cyclophotocoagulation

Study type

Interventional

Funder types

Other

Identifiers

NCT00349414
DSRB Reference Code: A/06/164

Details and patient eligibility

About

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.

Full description

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.

Enrollment

70 estimated patients

Sex

All

Ages

22+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Grace Dizon, MD; Anna Tan, MMed

Data sourced from clinicaltrials.gov

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