| CTRI Number |
CTRI/2015/05/005813 [Registered on: 26/05/2015] Trial Registered Retrospectively |
| Last Modified On: |
25/05/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
retrospective |
| Study Design |
Other |
|
Public Title of Study
|
To Study the Outcomes of Insertion of a particular type of Lens into the eye under different Clinical Circumstances |
|
Scientific Title of Study
|
Retrospective study of evaluation of outcomes of retrofixated iris claw lenses in different scenarios |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kirti Relekar |
| Designation |
Senior Resident |
| Affiliation |
NETHRADHAMA SUPERSPECIALTY EYE HOSPITAL |
| Address |
256, 14 kanakapura main road
7th block, Jayanagar, Bangalore
256, 14 kanakapura main road
7th block, Jayanagar, Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
9820516075 |
| Fax |
|
| Email |
kirtirelekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kirti Relekar |
| Designation |
Senior Resident |
| Affiliation |
NETHRADHAMA SUPERSPECIALTY EYE HOSPITAL |
| Address |
256, 14 kanakapura main road
7th block, Jayanagar, Bangalore
256, 14 kanakapura main road
7th block, Jayanagar, Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
9820516075 |
| Fax |
|
| Email |
kirtirelekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kirti Relekar |
| Designation |
Senior Resident |
| Affiliation |
NETHRADHAMA SUPERSPECIALTY EYE HOSPITAL |
| Address |
256, 14 kanakapura main road
7th block, Jayanagar, Bangalore
256, 14 kanakapura main road
7th block, Jayanagar, Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
9820516075 |
| Fax |
|
| Email |
kirtirelekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL |
|
|
Primary Sponsor
|
| Name |
NETHRADHAMA SUPERSPECIALTY EYE HOSPITAL |
| Address |
256/14, KANAKAPURA MAIN ROAD, 7TH BLOCK JAYANAGAR, BANGALORE |
| 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 |
| Kirti Relekar |
NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL |
256/14, Kanakapura main road,
7th block Jayanagar, Nethradhama Eye Hospital, Phacorefractive department, OPD Block, Bangalore-560070
Bangalore
KARNATAKA |
09820516075
kirtirelekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
aphakia, subluxated lens, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All eyes which underwent retro-fixated iris claw lens implantation in our institute from January 2007 to December 2014. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate outcomes of retrofixated iris claw lenses in different scenarios |
Data assessed by January 2015 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2007 |
| 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="8"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this retrospective, Electronic medical records (EMR) data of all the
eyes which have undergone retrofixated iris claw lens implantation at our
institute will be analyzed in terms of safety and efficacy based on different pre operative and post
operative parameters.
|