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Evaluation of synthetic biopolymer in comparison to Human Amniotic Membrane in treatment of ocular chemical injury

Evaluation of modified poly epsilon caprolactone (pPCL) as a substitute for human amniotic membrane (HAM) graft in unilateral acute chemical injury : a pilot clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045944
Enrollment
20
Registered
2022-09-27
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: H578- Other specified disorders of eye and adnexa

Interventions

Intervention1: Use of Poly Epsilon Caprolactone membrane(pPCL)in acute ocular chemical injury: Recruitment of patients with acute ocular chemical injury followed by pre op investigation. Aplication of

Sponsors

Dr Rajendra Prasad Centre For Ophthalmic Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Unilateral acute chemical burns (Dua grade 3-6) presenting within 1 week. 2. Willing to participate follow up for atleast 3 months. 3 No systemic comorbidity/pregnency.

Exclusion criteria

Exclusion criteria: 1. Patients whose characteristics do not confirm to above criteria. 2. Patients with untreated concurrent problems such as adnexal problems or infection.

Design outcomes

Primary

MeasureTime frame
Percentage reduction in epithelial defect .Timepoint: Post operative day 3 and day 7—

Secondary

MeasureTime frame
Complete sucess- avascular cornea Partial sucess- mild vascularization not reaching upto centre of corneaTimepoint: Day 1,Day 3,Day 7,1,3,6 month—

Countries

India

Contacts

Public ContactKrishna Saini

RPC,AIIMS NEW DELHI

radhika_tan@yahoo.com9958834745

Outcome results

None listed

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