| CTRI Number |
CTRI/2018/04/012951 [Registered on: 03/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
06/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Safety and efficacy of transepithelial phototherapeutic keratectomy with accelerated corneal collagen cross linking in Keratoconus. |
|
Scientific Title of Study
|
Safety and efficacy of transepithelial phototherapeutic keratectomy with accelerated corneal collagen cross linking in Keratoconus. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 29/2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinay S Pillai |
| Designation |
Sr Consultant Ophthalmologist |
| Affiliation |
Giridhar Eye Institute |
| Address |
Ponneth Temple Road
Kadavanthra
Cochin 682 020
Ernakulam
KERALA
682020
India |
| Phone |
8547720217 |
| Fax |
04844000584 |
| Email |
vinayspillai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay S Pillai |
| Designation |
Sr Consultant Ophthalmologist |
| Affiliation |
Giridhar Eye Institute |
| Address |
Ponneth Temple Road
Kadavanthra
Cochin 682 020
Ernakulam
KERALA
682020
India |
| Phone |
8547720217 |
| Fax |
04844000584 |
| Email |
vinayspillai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinay S Pillai |
| Designation |
Sr Consultant Ophthalmologist |
| Affiliation |
Giridhar Eye Institute |
| Address |
Ponneth Temple Road
Kadavanthra
Cochin 682 020
Ernakulam
KERALA
682020
India |
| Phone |
8547720217 |
| Fax |
04844000584 |
| Email |
vinayspillai@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Giridhar Eye Institute |
| Address |
Ponneth Temple Road
Kadavanthra
Cochin 682 020 |
| 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 |
| Dr Vinay S Pillai |
Giridhar Eye Institute |
Ponneth Temple Road
Kadavanthra
Cochin 682 020
Ernakulam
KERALA |
8547720217
04844000584
vinayspillai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Giridhar Eye Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
(b) Diagnosed as Keratoconus
(b) Steepest keratiometry more than 47D
(c) Corneal thinnest point 400 micron or more
(d) Age 18 years to 50 years |
|
| ExclusionCriteria |
| Details |
(a) History or corneal disease
(b) Corneal thinnest point less than 400 micron
(c) Patient not willing or unable to return for schedule of protocol visits
(d) Any associated ocular co-morbidities
(e) Age less than 18 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the safety and efficacy of transepithelial phototherapeutic keratectomy (t-PTK) with accelerated corneal collagen cross linking (ACXL) in Keratoconus. |
12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual outcome, astigmatic changes, changes in corneal clarity will be assessed and intra-operative and post-operative complications shall be observed. |
12 Months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/07/2017 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective observational study to study the safety and efficacy of transepithelial phototherapeutic keratectomy (t-PTK) with accelerated corneal collagen cross linking in Keratoconus. Patients attending the cornea services of Giridhar Eye Institute and diagnosed as having keratoconus will be selected. 50 consecutive cases of keratoconus which undergoes t-PTK with ACXL will be included in the study.
|