| 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
|
|
|
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
|
|
|
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.
|