FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/10/028267 [Registered on: 07/10/2020] Trial Registered Prospectively
Last Modified On: 06/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Visual function & Ocular Parameter evaluation in children with Retinopathy of prematurity treated with laser 
Scientific Title of Study   ocular biometric profile and visual function development in children with retinopathy of prematurity treated with laser 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Riya bramhapurikar 
Designation  Resident (DNB) Ophthalmology 
Affiliation  Sankara Eye Hospital, Bangalore 
Address  Sankara Eye Hospital , Varthur Main Road, kundanahalli gate, Bangalore

Bangalore
KARNATAKA
560037
India 
Phone  8208691512  
Fax    
Email  riyabramhapurikar1994@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kaushik Murali 
Designation  Head Dept of Paediatric Ophthalmology 
Affiliation  Sankara Eye Hospital, Bangalore 
Address  Sankara Eye Hospital , Varthur Main Road, Kundanahalli gate, Bangalore

Bangalore
KARNATAKA
560037
India 
Phone  9739000096  
Fax    
Email  kaushik@sankaraeye.com  
 
Details of Contact Person
Public Query
 
Name  Dr Riya bramhapurikar 
Designation  Resident (DNB) Ophthalmology 
Affiliation  Sankara Eye Hospital, Bangalore 
Address  Sankara Eye Hospital , Varthur Main Road, Kundanahalli gate, Bangalore

Bangalore
KARNATAKA
560037
India 
Phone  8208691512  
Fax    
Email  riyabramhapurikar1994@gmail.com  
 
Source of Monetary or Material Support  
Sankara Eye Hospital Bangalore 
 
Primary Sponsor  
Name  Sankara Eye Hospital Bangalore 
Address  Varthur road, Kundanahalli gate, Bangalore 560037 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Riya Bramhapurikar  Sankara eye hospital, Bangalore  Varthur road, Kundanahalli gate, Bangalore. 560037
Bangalore
KARNATAKA 
8208691512

riyabramhapurikar1994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Sankara Eye Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H351||Retinopathy of prematurity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1. Children with ROP treated with laser
2. Children with ROP treated with LASER and supplementary treatment like intravitreal anti VEGF injections. 
 
ExclusionCriteria 
Details  1.Children with ROP post vitreoretinal surgery.
2.Children with additional eye surgeries
3.ROP children with macular pathology
4.Children with systemic conditions preventing examination for parameters of ocular biometry.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effect on Functional Vision and Biometry following LASER in ROP  Base Line , 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Improvement in functional vision on vision stimulation
2. Change in biometry and visual function on follow-up
3. Comparision of various ocular biometric parameters in terms of refractive status 
last follow up 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/10/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Retinopathy of prematurity (ROP), is a vasoproliferative retinal disorder unique to premature infants. It is a spectrum of disease which clinically varies from spontaneous regression to bilateral retinal detachment and total blindness. Laser photocoagulation is one of the treatment modalities when given in type 1 ROP improves structural and visual acuity outcomes. Green laser(532nm) and diode laser(810nm) are used for ROP treatment.

Studies in terms of anatomical and refractive parameters in ROP children treated with laser were done in the past. However, clarity on the factors leading to myopia in these children is still lacking.

Functional vision is the use of vision for particular purposes. Functional visual skills are required to carry out everyday activities. Functional visual assessment is done in patients with low vision to see the difference in the measured visual acuity(distance and near) and how the person use vision as these 2 factors are not usually related to each other.

Previous studies showed that visual stimulation in form of various designs have the potential to improve visual outcomes in children with visual impairment. Role of Visual stimulation in ROP children treated with Laser needs to be evaluated further.

Through this study a more comprehensive way of understanding ocular biometric parameters in relation to ocular morbidities associated with ROP with additional component of functional visual assessment in ROP children with laser is what we wish to perform.

 

 
Close