| CTRI Number |
CTRI/2017/05/008578 [Registered on: 16/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
03/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Childhood Keratoconus - A Corneal Disease |
|
Scientific Title of Study
|
Epidemiology, Clinical profile & Management Outcomes Of Keratoconus in Pediatric Age Group |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yogita |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, Delhi |
| Address |
Dr R.P. Center for Ophthalmic Sciences,
All India Institute of Ophthalmic Sciences,
Ansari Nagar
New Delhi,
India
100/1a, Third floor Surya apartment, Gautam nagar, Delhi
South
DELHI
110029
India |
| Phone |
09868358359 |
| Fax |
|
| Email |
yogitagupta30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Namrata Sharma |
| Designation |
Professor of Ophthalmology |
| Affiliation |
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, Delhi |
| Address |
Room no 444, 4th floor,
Dr R.P. Center for Ophthalmic Sciences,
All India Institute of Ophthalmic Sciences,
Ansari Nagar
New Delhi,
India
South
DELHI
110029
India |
| Phone |
01126593144 |
| Fax |
|
| Email |
namrata.sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yogita |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, Delhi |
| Address |
Dr R.P. Center for Ophthalmic Sciences,
All India Institute of Ophthalmic Sciences,
Ansari Nagar
New Delhi,
India
South
DELHI
201301
India |
| Phone |
09868358359 |
| Fax |
|
| Email |
yogitagupta30@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, Delhi |
| 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 Yogita Gupta |
All India institute of Medical Sciences |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences
(Department of Ophthalmology)
Ansari Nagar,
New Delhi
South
DELHI |
9868358359
9868358359
yogitagupta30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Diagnosed cases of unilateral/bilateral KC in pediatric population (18 years of age), , (1) ICD-10 Condition: H186||Keratoconus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Trial of glasses or contact lenses/ Corneal collagen cross-linking/ Deep Anterior Lamellar Keratoplasty/ Penetrating keratoplasty |
Cases were managed as per Keratoconus Global Consensus Guidelines, 2015 given by Cornea Society, which was used to decide the intervention to be done in each patient.. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of unilateral/bilateral KC in pediatric population (<18 years of age), recruited from Cornea Clinic and Contact Lens Clinic of R.P. Centre, AIIMS over a one year study period. |
|
| ExclusionCriteria |
| Details |
Parents not willing to give consent for participation/follow-up.
Patients with any ocular/systemic co-morbidity requiring immediate attention.
Patients with previous surgical intervention done in the past. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Demographic and clinical profile of keratoconus in pediatric age group |
Once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Management outcomes of keratoconus in pediatric age group |
Day 0, Month 1, Month 3, Month 6 and Month 12. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Gupta Y, Sharma N, Maharana PK, Saxena R, Sinha R, Agarwal T, Jhanji V, Titiyal JS. Pediatric Keratoconus: Topographic, Biomechanical and Aberrometric Characteristics. Am J Ophthalmol. 2021 May;225:69-75. doi: 10.1016/j.ajo.2020.12.020. Epub 2020 Dec 29. PMID: 33385369. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aims & Objectives To study the epidemiological & clinical features and management outcomes in cases of keratoconus in pediatric age group (<18 years).
Study Design: Prospective non-randomized interventional study Inclusion Criteria : Age: <18 years of age Diagnosed cases of unilateral/bilateral KC. Diagnosis of keratoconus will be based on the presence of the following three findings mandatorily16:  Abnormal posterior corneal elevation  Abnormal corneal thickness distribution  Clinical non-inflammatory corneal thinning Exclusion Criteria : • Patients with any surgical intervention in the eye(s) done previously. • Parents not willing to give consent for participation/follow-up. Plan of Study: Patients will be taken from the inpatient and outpatient department, Cornea Clinic and Contact Lens Clinic of Dr. Rajendra Prasad Centre for Ophthalmic Sciences and will be included or excluded based on the inclusion/exclusion criteria. Patients following up in period of 1 year of the study will be included. Institutional ethics committee approval has been obtained and tenets of Helsinki declaration shall be observed. |