| CTRI Number |
CTRI/2018/03/012741 [Registered on: 22/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
06/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Chart Review |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
LASIK SURGERY |
|
Scientific Title of Study
|
Scheimpflug Imaging assisted measurement of pre-corneal tear film thickness and its changes after LASIK. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashob Mohan |
| Designation |
Consultant Ophthalmologist |
| Affiliation |
Giridhar Eye Institute |
| Address |
Ponneth Temple Road
Kadavanthra
Cochin
Ernakulam
KERALA
682020
India |
| Phone |
914844170000 |
| Fax |
914844000584 |
| Email |
prashmn@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashob Mohan |
| Designation |
Consultant Ophthalmologist |
| Affiliation |
Giridhar Eye Institute |
| Address |
Ponneth Temple Road
Kadavanthra
Cochin
Ernakulam
KERALA
682020
India |
| Phone |
914844170000 |
| Fax |
914844000584 |
| Email |
prashmn@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashob Mohan |
| Designation |
Consultant Ophthalmologist |
| Affiliation |
Giridhar Eye Institute |
| Address |
Ponneth Temple Road
Kadavanthra
Cochin
Ernakulam
KERALA
682020
India |
| Phone |
914844170000 |
| Fax |
914844000584 |
| Email |
prashmn@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Giridhar Eye Institute
Ponneth Temple Road
Kadavanthra
Cochin 682020 |
|
|
Primary Sponsor
|
| Name |
Giridhar Eye Institute |
| Address |
Ponneth Temple Road
Kadavanthra
Cochin-682 020, India |
| 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 Prashob Mohan |
Giridhar Eye Institute |
Ponneth Temple Road
Kadavanthra
Cochin 682020
Ernakulam
KERALA |
914844170000
914844000584
prashmn@yahoo.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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
All patients willing to undergo LASIK treatment |
|
| ExclusionCriteria |
| Details |
(a) Patients with corneal erosions, keratitis, corneal ectasia, corneal scars and abnormality of lacrimal drinage apparatus will be excluded from the study (b) Patients who are unable to maintain sustained fixation on a near target will be excluded from the study (c) patients with contraindications for LASIK will be excluded from further evaluation (d) patients under the age of 18 will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Detect candidates who can potentially develop chronic tear film disfunction after LASIK with a scheimpflug camera based imaging system. |
18 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tear film thickness at the corneal apex will be evaluated and the pattern of each tear film pachymetry map will be determined. |
18 Months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/12/2017 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The pre-corneal tear film is an important component of the anatomy and physiology of the eye and performs several functions. It prevents the epithelial cells from dessication, facilitates eyelid movement by lubrication, provides a smooth refracting surface on the cornea, supplies nutrients and oxygen necessary for corneal metabolism, contributes to the ocular antimicrobial defense mechanism, removes metabolic waste products, eliminates foreign bodies from the ocular surface and protects the cornea and conjunctiva from atmospheric and chemical irritants.
The Wavelight Oculyzer is an instrument that uses a rotating camera to image the shape and thickness of the cornea using the Scheimpflug principles. Fluorescein is a dye that is commonly used to study the tear film. By adding fluorescein to the tear film the Wavelight Oculyzer can be used to non-invasively measure the thickness of the tear film.
LASIK (Laser In-Situ Keratomileusis) is one of the most commonly performed cornea refractive surgeries to provide spectacle free vision. It involves creation of a partial thickness flap of the cornea, reflection of the flap, application of excimer laser (wavelength 193 nm) to ab late corneal tissue followed by replacement of the flap.
Aims and Objectives:
(a) To devise a novel method for measuring the pre-corneal tear film thickness. (b) To study the changes in pre-corneal tear film thickness that occur after LASIK. (c) To examine the utility of a Scheimpflug Camera based imaging system as a non-invasive objective tool to detect candidates who can potentially develop chronic tear film dysfunction after LASIK. |