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"Comparison of a laser procedure for glaucoma with the current standard filtration operation, when either of it is combined with cataract operation, in the presence of a specific type of glaucoma (angle closure) and lens haziness (cataract)"

Randomised Control Trial of Phaco-EndocycloPhotocoagulation vs Phacotrabeculectomy in medically controlled and uncontrolled primary angle closure disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/04/005733
Enrollment
200
Registered
2015-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- medically controlled and uncontrolled Primary Angle Closure Disease, post laser peripheral iridotomy

Interventions

Intervention1: Phaco-Endocyclophotocoagulation: â?¢Will be performed in the OR under regional anaesthesia â?¢Clear corneal phaco will be done and intra-ocular lens implant (PCIOL) inserted. â?¢Endosc
â??popsâ?? will be strictly avoided. â?¢At the end of the procedure, viscoelastic will be washed and sub-conjunctival steroid and antibiotic will be administered (Dexamethasone 2mg and Gentamicin 20mg
conjunctiva will be closed with 10/0 vicryl running mattress sutures. â?¢At the end of the procedure, viscoelastic will be washed and sub-conjunctival steroid

Sponsors

LV Prasad Eye Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Age >=30 years •Primary Angle Closuredisease (PAC and PACG) subjects post LPI. Primary Angle Closure (PAC)is defined by presence of occludable angles on standard 4-mirror gonioscopy (posterior trabecular meshwork not visible, either appositional or synaechial, for 2 or more quadrants) with presence of peripheral anterior synaechiae and/or blotchy pigment. Primary Angle Closure Glaucoma (PACG) is defined defined by glaucomatous optic disc changes with corresponding visual field changes in the presence of occludable angles. PAC and PACGwho have had laser LaserPeripheral Iridotomy (LPI) will undergo randomized study procedure •When IOP is uncontrolled •When IOP is controlled on 3 or more anti-glaucoma medication and / or 10-2 HVF shows involvement of fixation •Intolerant to or unable to afford anti-glaucoma medication •Lens status â?? presence of visually significant cataract (20/40 or less), glaucomflecken

Exclusion criteria

Exclusion criteria: •Age •Unwillingness or inability to participate •Blepharitis, dacryocystitis or any other ocular surface infection •Any intra-ocular surgery •Any cause for secondary glaucoma •One-eyed subject •Depression of any paracentral point on 10-2 of Humphrey Visual Field to 0 dB

Design outcomes

Primary

MeasureTime frame
Reduction in intraocular pressure by 2 criteria number of eyes achieving an IOP of less than or equal to 18 with or without anti-glaucoma medications in both the groups at the end of 1 year.Timepoint: 1 day, 1 week, 1 month, 3 months, then at 4 monthly intervals till 1 year—

Secondary

MeasureTime frame
glaucoma medications, major complications (as defined) and factors associated with outcome.Timepoint: 1 day, 1 week, 1 month, 3 months, then at 4 monthly intervals till 1 year—

Countries

India

Contacts

Public ContactDr Vanita Pathak Ray

L V Prasad Eye Institute

docvanita@lvpei.org040-30612631

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026