| CTRI Number |
CTRI/2020/08/027339 [Registered on: 24/08/2020] Trial Registered Prospectively |
| Last Modified On: |
13/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Changes in vision and eye structure after lens surgery in children |
|
Scientific Title of Study
|
Visual outcome and biometric changes following surgery in unilateral and bilateral cataract in paediatric population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirupama Kasturi |
| Designation |
Associate Professor |
| Affiliation |
Department of Ophthalmology, JIPMER |
| Address |
Dept. of Ophthalmology
JIPMER
Dhanvantri nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
918903557413 |
| Fax |
|
| Email |
kasturiniru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nirupama Kasturi |
| Designation |
Associate Professor |
| Affiliation |
Department of Ophthalmology, JIPMER |
| Address |
Dept. of Ophthalmology
JIPMER
Dhanvantri nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
918903557413 |
| Fax |
|
| Email |
kasturiniru@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nirupama Kasturi |
| Designation |
Associate Professor |
| Affiliation |
Department of Ophthalmology, JIPMER |
| Address |
Dept. of Ophthalmology
JIPMER
Dhanvantri nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
918903557413 |
| Fax |
|
| Email |
kasturiniru@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER Alumni association of North America(JAANA) research grant
JAANA, USA |
|
|
Primary Sponsor
|
| Name |
JAANA |
| Address |
USA |
| Type of Sponsor |
Other [Alumni association of JIPMER] |
|
|
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 |
| NIRUPAMA kASTURI |
JIPMER |
OPD room no. 15, Dept. of Ophthalmology
Pondicherry
PONDICHERRY |
8903557413
kasturiniru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H260||Infantile and juvenile cataract, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Paediatric patients (<5 years of age) diagnosed with congenital cataract and undergoing cataract surgery
Central cataract, >3mm in visual axis, associated with squint or nystagmus
|
|
| ExclusionCriteria |
| Details |
Corneal opacity or preexisting retinal/ optic nerve pathology or children developing secondary glaucoma will be excluded from the study
Children with microcephaly or mental retardation which will affect visual outcome
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual acuity
Keratometry
Axial length |
Baseline, 1 year and 5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications |
1 year, 5 years |
|
|
Target Sample Size
|
Total Sample Size="121"
Sample Size from India="121"
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)
|
01/01/2021 |
| 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="2"
Months="0"
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)?
|
|
Brief Summary
|
The purpose of the trial is to assess the visual outcome and ocular biometric changes following paediatric cataract surgery. The findings of the trial will enable to modify the intra-ocular lens power for better visual and refractive outcomes in future.
|