Skip to content

Clinical trial to study the effect of using a filtration surgery to reduce eye pressure called Trabeculectomy (creating new opening at angle) alone compared to a combination of Trabeculectomy and a deep sclerectomy (removing extra white tissue of eye) surgery for glaucoma

Comparative evaluation of trabeculectomy v/s trabeculectomy combined with deep sclerectomy.- A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013005
Enrollment
60
Registered
2018-04-04
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: null- mod-advanced primary glaucoma: Hodapp-Parish-Anderson (MD worse than ââ?¬â?? 6.0 dB) and primary angle closure glaucoma with pseudophakia Health Condition 2: H401- Open-angle glaucoma

Interventions

Intervention1: Trabeculectomy: Under aseptic surgical technique, a corneal traction suture will be placed using 6-0 vicryl and a fornix/limbal-based conjunctival flap is created. Sub-Tenon dissection

Sponsors

All India Institute Of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ââ?¬Â¢ Patients with mod-advanced primary glaucoma: Hodapp-Parish-Anderson (MD worse than ââ?¬â?? 6.0 dB) and primary angle closure glaucoma with pseudophakia ââ?¬Â¢ Age > 40 years IOP not controlled on maximum tolerable medical therapy ââ?¬Â¢ Patient willing to give informed consent and able to comply with study procedures

Exclusion criteria

Exclusion criteria: � One eyed patients � History of previous glaucoma surgery or Laser Trabeculoplasty � Cataract surgery within 12 months in the same eye � Pregnant or breast feeding women

Design outcomes

Primary

MeasureTime frame
Intraocular pressureTimepoint: Post operative day 1, day 7, 1 month, 3 months, 6 months

Secondary

MeasureTime frame
Anterior Segment Optical Coherence Tomography (ASOCT) bleb gradingTimepoint: Post operative 1, 3 and 6 months;Bleb morphology on slit lamp Timepoint: Post operative 1 month, 3 months, 6 months;Height and width of intrascleral aqueous lake and Suprachoroidal flow (UBM)Timepoint: postoperative 3, 6 months

Countries

India

Contacts

Public ContactArpit Sharma

All India Institute Of Medical Sciences

tanujdada@gmail.com

Outcome results

None listed

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