TO COMPARE TWO MODES OF TREATMENT IN A DISEASE AFFECTING THE INNER LAYERS OF THE EYE (RETINA) IN PREMATURE BABIES (RETINOPATHY OF PREMATURITYONE EYE-LASER TREATMENT (LIGHT RADIATION) OTHER EYE-LASER AND INJECTION (OF A COMPOUND WHICH PREVENTS ABNORMAL NEW VESSEL FORMATIO
Not Applicable
Completed
- Conditions
- Health Condition 1: H351- Retinopathy of prematurity
- Registration Number
- CTRI/2019/10/021635
- Lead Sponsor
- Dr Parijat chandra
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
1.PRETERM BABIES WITH GA <34WEEKS/ BIRTH WEIGHT <200G
2.B/L SYMMETRICAL THRESHOLD ROP
- ZONE 1 OR 2 STAGE 3 ROP WITH PLUS DISEASE
-EXTENT >5 CONTIGUOUS CLOCK HOURS OR >8 NON-
CONTIGUOUS CLOCK HOURS
-PLUS DISEASE
3.NO PREVIOUS TREATMENT FOR ROP
Exclusion Criteria
1. PRE-THRESHOLD ROP
2. ADVANCED ROP STAGE 4/5
3. PREVIOUS LASER /ANTI-VEGF TREATMENT
4. OTHER OCULAR ABNORMALITY
5. BABIES WHOSE PARENTS ARE UNWILLING TO GIVE
CONSENT FOR SURGERY
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare outcomes of laser vs combined laser & ranibizumab in regression of threshold ROP.Timepoint: 12 WEEKS
- Secondary Outcome Measures
Name Time Method To compare the outcomes of laser vs combined laser & ranibizumab in management of threshold ROP in terms of recurrence of ROP with need for additional treatmentTimepoint: 12 WEEKS