| CTRI Number |
CTRI/2020/10/028189 [Registered on: 01/10/2020] Trial Registered Prospectively |
| Last Modified On: |
30/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Screening of siblings, parents,childrens of keratoconus,suspect keratoconus |
|
Scientific Title of Study
|
Clinical and topographical evaluation of first degree relatives of patients with Keratoconus and Suspect Keratoconus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alla snehitha |
| Designation |
Resident (Postdo DNB)ophthalmology |
| Affiliation |
Sankara eye hospital shimoga |
| Address |
Sankara eye hospital
Harakere
Sankara eye hospital
Harakere
Shimoga
KARNATAKA
577202
India |
| Phone |
9966535509 |
| Fax |
|
| Email |
drsnehitha.a7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRavishankar H N |
| Designation |
Head of the department of Vitreoretina services |
| Affiliation |
Sankara eye hospital shimoga |
| Address |
Sankara eye hospital
Harakere
Sankara eye hospital
Harakere
Shimoga
KARNATAKA
577202
India |
| Phone |
7760741115 |
| Fax |
|
| Email |
ravishankar@sankaraeye.com |
|
Details of Contact Person
Public Query
|
| Name |
Alla Snehitha |
| Designation |
Resident (Post do DNB) ophthalmology |
| Affiliation |
Sankara eye hospital shimoga |
| Address |
Sankara eye hospital
Harakere
Sankara eye hospital
Harakere
Shimoga
KARNATAKA
577202
India |
| Phone |
9966535509 |
| Fax |
|
| Email |
drsnehitha.a7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital Shimoga |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital Shimoga |
| Address |
Thirthahalli road
harakere
|
| 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 |
| ALLA SNEHITHA |
Sankara Eye Hospital |
Harakere
Shimoga
KARNATAKA |
9966535509
drsnehitha.a7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parents, siblings and children of keratoconus and suspect keratoconus. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)First degree relatives of patients with keratoconus and suspect keratoconus
2)Patients who give consent for study |
|
| ExclusionCriteria |
| Details |
1)Other ectatic disorders(PMD and keratoglobus)
2)Patient who are not cooperative for examinatins
3)Any ocular comorbidities hindering the acquisition of topography images
4)Concurrent ocular infections
5)Active ocular allergic conditions
6)Past history of ocular surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the early cases of KC in first degree relatives of KC patients and suspect KC |
NIL |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
02/10/2020 |
| 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="0"
Months="6"
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
|
keratoconus(KC) is a progressive disorder in which central or paracentral corneal stromal thinning occurs, accompained by apical protrusion and irregular astigmatism causing visual disturbances .KC is bilateral, often asymmetric and affects both the genders.
KC multifactorial resulting from the interaction of environment, genetic, behavioural factors.
Hereditary pattern is not prominent or predictable, but positive family history has been reported in 6-8%cases.subclinical cases of KC described in relatives of KC patients showed only subtle topographcal abnormalities As KC is known to progress ,identifying early cases of KC could lead to better vision preservation through corneal cross linking. There is scarcity of data in Indian population so we have chosen to screen the first degree relatives if KC patients |