| CTRI Number |
CTRI/2024/02/062208 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective case series |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Outcomes of both eye cataract surgery in single sitting in pediatric patients with cataract |
|
Scientific Title of Study
|
Immediate Sequential Bilateral Cataract Surgery in Pediatric patients at a tertiary care center in India: A Retrospective Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Anju Rastogi |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 219, Second floor, OPD block, Guru Nanak Eye Centre, New Delhi
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
dranjurastogi@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Meghna Sethi |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 219, Second floor, OPD Block, Guru Nanak Eye Centre, New Delhi
Central
DELHI
110002
India |
| Phone |
9560601175 |
| Fax |
|
| Email |
meghnasethi25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Meghna Sethi |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 219, Second floor, OPD Block, Guru Nanak Eye Centre, New Delhi
DELHI
110002
India |
| Phone |
9560601175 |
| Fax |
|
| Email |
meghnasethi25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Eye Centre, Maharaja Ranjeet Singh Marg, LNJP Colony, New Delhi, Delhi, 110002 |
|
|
Primary Sponsor
|
| Name |
MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITALS |
| Address |
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad
Medical College Campus, Balmiki Basti, New Delhi, Delhi 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Meghna Sethi |
Guru Nanak Eye Centre |
Room no. 219, Second floor, OPD Block, Guru Nanak Eye Centre, New Delhi
Central
DELHI |
9560601175
meghnasethi25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Maulana Azad 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 |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age group of 6 month to 12 years, with visually significant bilateral congenital or developmental cataract.
2. Axial length greater or equal to 17 mm in both eyes and difference between 2 eyes less than or equal to 1.5mm |
|
| ExclusionCriteria |
| Details |
1. Axial length more than 25mm.
2. Corneal opacities or corneal dystrophies.
3. Lens coloboma, microspherophakia, scleroderma
4. Subluxated lens, ectopia lentis
5. Coexisting glaucoma
6. Untreated blepharitis, meibomitis and dacryocystitis.
7. Complicated cataract e.g. cataract following uveitis, high myopia, hereditary retinal dystrophies like retinitis pigmentosa etc.
8. Traumatic cataracts
9. Posterior segment pathologies like RD or PHPV or colobomas etc.
10. Systemic diseases which increase the risk of infections like diabetes mellitus, collagen vascular disorders, mucopolysaccharidosis, patients on immunosuppressive drugs or suffering from immunocompromised diseases. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Refractive outcome Refractive error RE and Best corrected Visual Acuity BCVA in Immediate sequential bilateral cataract surgery ISBCS in children |
baseline, 3 weeks, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the duration of hospital stay and duration of operating room occupancy |
3 months |
| To evaluate the procedural surgical and anesthetic complications in Immediate sequential bilateral cataract surgery ISBCS if any |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/02/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
Pediatric cataract is a treatable leading cause
of childhood blindness. It accounts for 7.4%–15.3% of pediatric blindness of
which 60% cases are bilateral. Immediate Sequential Bilateral Cataract
Surgery (ISBCS) is gaining acceptance
across the globe as a result of its several medical, social and economical
benefits and the safety of the procedure. Outcomes and complications of immediate versus delayed sequential
bilateral cataract surgery in children can be studied and risks and benefits of
the two procedures can be compared. |