| CTRI Number |
CTRI/2024/12/078771 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Genetic studies on congenital cataract patients from North-India |
|
Scientific Title of Study
|
Genetic studies on some prevalent vision defects in Aligarh. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammad Afzal |
| Designation |
Professor (Retd.) |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Zoology
Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897839601 |
| Fax |
|
| Email |
afzal1235@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aal E Fatima |
| Designation |
Research Scholar |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Zoology
Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8532851383 |
| Fax |
|
| Email |
aalefatima1425@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammad Afzal |
| Designation |
Professor (Retd.) |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Zoology
Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897839601 |
| Fax |
|
| Email |
afzal1235@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Zoology, Aligarh Muslim University, Aligarh, Uttar Pradesh, India, Pin-202002 |
|
|
Primary Sponsor
|
| Name |
University Grants Commission |
| Address |
Bahadur Shah Zafar Marg,
New Delhi-110002. |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| UGC NonNET |
Bahadur Shah Zafar Marg,
New Delhi-110002. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Mohammad Afzal |
Jawaharlal Nehru Medical College |
Department of Ophthalmology,Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH |
9897839601
afzal1235@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Jawaharlal Nehru Medical College |
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
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with congenital cataracts, aged 0-18 years, either unilateral or bilateral, confirmed through clinical examination. |
|
| ExclusionCriteria |
| Details |
Patients having a history of intrauterine infection (TORCH), toxoplasmosis, others (hepatitis B, syphilis), rubella, cytomegalovirus, Herpes simplex virus; Other ocular clinical manifestations such as glaucoma, microcephaly, micro-opthalamos, uveal coloboma, and retinal disgeneration to rule out any systemic involvement
; Maternal history of steroid uses; Trauma
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study is expected to identify novel genetic mutations and provide a better understanding of the genetic and environmental factors contributing to congenital cataracts in North India. |
One Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary objectives include investigating familial patterns, exploring environmental interactions, & studying genetic variations across different ethnic groups.We also aim to develop genetic counseling guidelines for families at risk. |
Two Years |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
15/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/01/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 15-01-2026 and end date provided 31-12-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
India’s large, diverse population offers a unique opportunity to study the genetic basis of congenital cataracts. Regional, ethnic, and socioeconomic diversity may reveal population-specific mutations not seen globally. In North India, where genetic studies on congenital cataracts are scarce, identifying these mutations can aid early interventions and reduce childhood blindness. Current diagnostic approaches, relying on clinical examinations, fail to uncover genetic causes and limited access to genetic screening exacerbates the issue. This study aims to bridge this gap by improving diagnosis, treatment, and counseling. Findings will enhance genotype-phenotype understanding, inform healthcare strategies, and contribute to global genetic research on congenital cataracts. |