| CTRI Number |
CTRI/2026/02/104845 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Verification of results of PTK-PRK laser treatments for minus power correction based on epithelial thickness versus the results predicted by Epimaster software |
|
Scientific Title of Study
|
Clinical data collection of myopic patients after PTK-PRK with MEL excimer laser for verification of predicted refractive outcome using software EpiMaster considering epithelial remodelling |
| 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 Sheetal Brar |
| Designation |
Proffessor |
| Affiliation |
ProSight Eye Hospital |
| Address |
Phaco Refractive Department, Ground floor, Room number 1, ProSight Eye Hospital , SCO 146, sector 43 B
Chandigarh
CHANDIGARH
160043
India |
| Phone |
09591002092 |
| Fax |
|
| Email |
sheetalbrar1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Brar |
| Designation |
Proffessor |
| Affiliation |
ProSight Eye Hospital |
| Address |
Phaco Refractive Department, Ground floor, Room number 1, ProSight Eye Hospital , SCO 146, sector 43 B
Chandigarh
CHANDIGARH
160043
India |
| Phone |
09591002092 |
| Fax |
|
| Email |
sheetalbrar1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheetal Brar |
| Designation |
Proffessor |
| Affiliation |
ProSight Eye Hospital |
| Address |
Phaco Refractive Department, Ground floor, Room number 1, ProSight Eye Hospital , SCO 146, sector 43 B
Chandigarh
CHANDIGARH
160043
India |
| Phone |
09591002092 |
| Fax |
|
| Email |
sheetalbrar1@gmail.com |
|
|
Source of Monetary or Material Support
|
| ProSight Eye Hospital
sco 146 sector 43 B Chandigarh 160043 |
|
|
Primary Sponsor
|
| Name |
London Vision Clinic |
| Address |
138 Harley Street
London W1G7LA
United Kingdom |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Sheetal Brar |
ProSight Eye Hospital |
Phaco Refractive Department, Ground floor, Room number 1, ProSight Eye Hospital , SCO 146, sector 43 B
Chandigarh
CHANDIGARH |
09591002092
sheetalbrar1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chandigarh University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Myopia and myopic astigmatism |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Epimaster software |
Epimaster software is an advanced software to predict the outcome of TK PRK laser treatments |
| Intervention |
PTK PRK treatment |
PTK PRK treatment is a standard excimer laser based treatment for correction of myopia and myopic astigmatism |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria are according to the user manual of Carl Zeiss Meditec MEL (mel) 90 excimer laser for treatment of refractive errors
Patient present with myopic or myopic and astigmatic error
Patient will be able to understand the patient information and willing to sign an informed consent
Patient will be willing to comply with all follow-up visits and the respective examinations
|
|
| ExclusionCriteria |
| Details |
Thin corneas, keratoconus, corneal scars, severe eye allergies, eye infections, retinal and optic nerve diseases, pregnant females and immunocompromised patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| percentage of eyes with SE6 months post-op „measured“ - SEpredicted by EpiMaster within ±1.00D, with SE being the spherical equivalent |
post op 1, 3 , 6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of eyes that reached:
SE6 months post-op „measured" - SEpredicted by EpiMaster within ±0.50D
SE12 months post-op „measured" - SEpredicted by EpiMaster within ±1.00D
SE12 months post-op „measured" - SEpredicted by EpiMaster within ±0.50D
S6 months post-op „measured" - Spredicted by EpiMaster within ±1.00D
S6 months post-op „measured" - Spredicted by EpiMaster within ±0.50D
S12 months post-op „measured" - Spredicted by EpiMaster within ±1.00D
S12 months post-op „measured" - Spredicted by EpiMaster within ±0.50D
C6 months post-op „measured" - Cpredicted by EpiMaster within ±1.00D
|
post op 1, 3 , 6 & 12 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
16/03/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
The objective of this observational clinical investigation is to collect pre- and post-operative clinical data of PTK-PRK treatment for refractive cases for verification of EpiMaster software. The EpiMaster software is designed to predict the refractive outcome post-operative considering the epithelium remodelling effecting the final manifest refraction. It is an open, non-randomized, observational, prospective, single centre clinical investigation. Patients who are potential candidates for primary refractive treatment with MEL 90 excimer laser device according to the user manual of a Carl Zeiss Meditec MEL 90 excimer laser.Each patient will be followed at 1, 3 , 6 and 12 months after PTK-PRK treatment. Data analysis will be done at 12 months. Any serious adverse events will be reported to ethics commiteee within 48 hours. |