| CTRI Number |
CTRI/2025/09/095287 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Recovery and Shape Changes of the Eye’s Clear Front Layer after Laser Surgery for Nearsightedness and Distorted Vision due to Uneven Surface |
|
Scientific Title of Study
|
Corneal Epithelial Remodeling and Corneal Asphericity after Transepithelial Photorefractive Keratectomy for Myopia and Myopic Astigmatism |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suprita Boodur |
| Designation |
Resident (Primary DNB) Ophthalmology |
| Affiliation |
Sankara Eye Hospital, Coimbatore |
| Address |
Sankara Eye Hospital, (formerly known as Shri Kanchi Kamakoti Medical
Trust Hospital),
No.16-A, Sankara Eye Hospital Street, Sivanandapuram, Sathy Road,
Saravanampatti, Coimbatore
Tamil Nadu
641035
Coimbatore
TAMIL NADU
641035
India |
| Phone |
8867645659 |
| Fax |
|
| Email |
supritaboodur1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagadeesh Kumar Reddy |
| Designation |
Senior Consultant, Department of Cornea |
| Affiliation |
Sankara Eye Hospital, Coimbatore |
| Address |
Sankara Eye Hospital, (formerly known as Shri Kanchi Kamakoti Medical
Trust Hospital),
No.16-A, Sankara Eye Hospital Street, Sivanandapuram, Sathy Road,
Saravanampatti, Coimbatore
Tamil Nadu
641035
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9443047456 |
| Fax |
|
| Email |
reddyjk@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suprita Boodur |
| Designation |
Resident (Primary DNB) Ophthalmology |
| Affiliation |
Sankara Eye Hospital, Coimbatore |
| Address |
Sankara Eye Hospital, (formerly known as Shri Kanchi Kamakoti Medical
Trust Hospital),
No.16-A, Sankara Eye Hospital Street, Sivanandapuram, Sathy Road,
Saravanampatti, Coimbatore
Tamil Nadu
641035
Coimbatore
TAMIL NADU
641035
India |
| Phone |
8867645659 |
| Fax |
|
| Email |
supritaboodur1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, (formerly known as Shri Kanchi Kamakoti Medical
Trust Hospital),
No.16-A, Sankara Eye Hospital Street, Sivanandapuram, Sathy Road,
Saravanampatti, Coimbatore
Tamil Nadu
641035
India |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital, Coimbatore |
| Address |
Sankara Eye Hospital, (formerly known as Shri Kanchi Kamakoti Medical
Trust Hospital),
No.16-A, Sankara Eye Hospital Street, Sivanandapuram, Sathy Road,
Saravanampatti, Coimbatore
Tamil Nadu
641035 |
| 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 Suprita Boodur |
Sankara Eye Hospital, Coimbatore |
Sankara Eye Hospital, (formerly known as Shri Kanchi Kamakoti Medical
Trust Hospital),
No.16-A, Sankara Eye Hospital Street, Sivanandapuram, Sathy Road,
Saravanampatti, Coimbatore
Tamil Nadu
641035
Coimbatore
TAMIL NADU |
8867645659
supritaboodur1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Sankara Eye Hospital, Coimbatore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H188||Other specified disorders of cornea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients 21 to 40 years with Myopia and Myopic astigmatism
2.Patients with stable refraction for atleast 1 year
3.Spherical myopia less than -5.5 D
4.Astigmatism less than -3.5 D |
|
| ExclusionCriteria |
| Details |
1.Patients with dry eye
2.Patients with corneal scar
3.Patients with thinnest pachymetry value less than 470 microns
4.Patients with co-existing ocular diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of Changes in corneal epithelial thickness and Q-value (asphericity) using anterior segment OCT post Transepithelial Photorefractive Keratectomy |
at baseline, 4 weeks, 12 weeks, and 24 weeks post-Transepithelial Photorefractive Keratectomy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation between corneal epithelial thickness changes and visual acuity at each postoperative follow-up.
|
On follow up visits of 1st , 3rd and 6th month |
| Comparison of epithelial remodeling patterns (central, paracentral, and mid-peripheral thickness changes) between Patients with simple myopia and Patients with myopic astigmatism |
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
10/10/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective observational study will be conducted at Sankara Eye Hospital, Coimbatore, on 45 patients with myopia or myopic astigmatism undergoing transepithelial photorefractive keratectomy (Trans-PRK) using the Schwind Amaris 1050 excimer laser. The corneal epithelium has a non-uniform thickness and undergoes remodeling after refractive surgery, which can influence corneal curvature, asphericity (Q-value), and visual outcomes. Patients will be followed up at 1 month, 3 months, and 6 months. At each visit, visual acuity, corneal epithelial thickness mapping at central (2 mm), paracentral (2–4 mm), and peripheral (4–6 mm) zones using Anterion, and Q-value analysis will be performed. The primary objective is to evaluate epithelial remodeling and corneal asphericity after Trans-PRK. Secondary objectives include correlation of remodeling with visual acuity and comparison of epithelial remodeling patterns between spherical myopia and myopic astigmatism. The study is expected to provide insights into epithelial healing patterns, their impact on optical quality, and guidance for improving refractive surgery planning and outcomes. |