To compare the safety and efficacy of amniotic membrane transplantation and cord blood serum in cases of acute chemical injury of the eye
- Conditions
- Burn of eye and adnexa, part unspecified,
- Registration Number
- CTRI/2014/09/005067
- Brief Summary
PURPOSE: A PROSPECTIVE RANDOMIZED CONTROLLED CLINICAL TRIAL TO COMPARE THE SAFETY AND EFFICACY OF TOPICAL CORD BLOOD SERUM DROPS AND AMNIOTIC MEMBRANE TRANSPLANTATION IN ACUTE CHEMICAL INJURY
DESIGN: RANDOMIZED, CONTROLLED, CLINICAL TRIAL
PARTICIPANTS AND CONTROLS: PARTICIPANTS WITH ACUTE CHEMICAL INJURY WERE RANDOMIZED INTO 3 GROUPS
INTERVENTION: GROUP 1 TREATED WITH STANDARD TREATMENT, GROUP 2 WITH AMNIOTIC MEMBRANE GRAFT IN ADJUNCTION TO STANDARD TREATMENT, GROUP 3 TREATED WITH CORD BLOOD SERUM IN ADJUNTION TO STANDARD TREATMENT
MAIN OUTCOME MEASURES: VISUAL ACUITY, DUA’S CLASSIFICATION, CORNEAL CLARITY, LIMBAL INVOLVEMENT, EPITHELIAL DEFECT, PAIN SCORE, TEAR FILM STATUS, INTRAOCULAR PRESSURE, OTHER COMPLICATIONS
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 45
GRADE 3,4,5 CHEMICAL INJURY AS PER DUAS CLASSIFICATION PRESENTING WITH IN 3 WKS OF INJURIES.
GRADE 1,2,6 CHEMICAL INJURY AS PER DUAS CLASSIFICATION PRESENTING WITH IN 3 WKS OF INJURIES 2.IMPENDING PERFORATION OR PERFORATION AT PRESENTATION 3.NOT WILLING FOR PARTICIPATION OR FOLLOW UP.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.VISUAL ACUITY 3 MONTHS 5.LIMBAL INVOLVEMENT 3 MONTHS 2.DUAS CLASSIFICATION 3 MONTHS 3.CORNEAL CLARITY 3 MONTHS 4.EPITHELIAL DEFECT 3 MONTHS
- Secondary Outcome Measures
Name Time Method 1.PAIN SCORE 2.TEAR FILM STATUS
Trial Locations
- Locations (1)
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS
🇮🇳South, DELHI, India
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS🇮🇳South, DELHI, IndiaDr Namrata SharmaPrincipal investigator09810856988namrata.sharma@gmail.com