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A study evaluating the Efficacy of Sub-Tenon Mitomycin C Trabeculectomy with and without Amniotic Membrane Transplantation as an Adjunct

A Randomised Controlled Trial to Evaluate the Efficacy of Sub-Tenon Mitomycin C Trabeculectomy with and without Amniotic Membrane Transplantation as an Adjunct in a Tertiary Care Centre - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065109
Enrollment
42
Registered
2024-04-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: H401- Open-angle glaucoma Health Condition 2: H402- Primary angle-closure glaucoma Health Condition 3: H403- Glaucoma secondary to eye trauma Health Condition 4: H408- Other glaucoma Health Condition 5: O- Medical and Surgical

Interventions

Intervention1: TRABECULECTOMY WITH SUB-TENON MITOMYCIN C AND AMNIOTIC MEMBRANE TRANSPLANTATION UNDER LOCAL ANAESTHESIA: subtenon injection of mitomycin c 0.02% combined with Amniotic membrane placed

Sponsors

Dr Siddhant Relekar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of open-angle glaucoma and angle-closure glaucoma fulfilling the following criteria were included 1.IOP more than 21 mmHg despite using IOP-lowering medications 2.Patients willing for 3-month follow-up and investigations

Exclusion criteria

Exclusion criteria: A history of prior surgical interventions in the form of past glaucoma filtering surgery, cataract surgery, or any other surgery involving conjunctiva, or co-existing conjunctival disease

Design outcomes

Primary

MeasureTime frame
This study will provide further insight into the efficacy of amniotic membrane transplantation as an adjunct to sub-tenon Mitomycin trabeculectomyTimepoint: pre-operative post operative 3 month

Secondary

MeasureTime frame
This study will provide further insight into the efficacy of amniotic membrane transplantation as an adjunct to sub-tenon Mitomycin trabeculectomyTimepoint: post operative day 1 post operative day 7

Countries

India

Contacts

Public ContactDr Rekha Mudhol

Shri B .M .Patil Medical College Hospital and Research centre

rekhamudhol@gmail.com9449938997

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026