| CTRI Number |
CTRI/2022/06/043607 [Registered on: 30/06/2022] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Investigation of laser for eye treatment |
|
Scientific Title of Study
|
Clinical Investigation of the WaveLight® UV Femtosecond Laser for Corneal Flap Creation |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit Shetty |
| Designation |
Cornea & Refractive Surgeon, Clinical Scientist |
| Affiliation |
Narayana Nethralaya |
| Address |
Main center
Narayana Nethralaya 01
121 C Chord Rd Near Iskcon Temple 1st R Block Rajajinagar Bengaluru
Bangalore
KARNATAKA
560010
India |
| Phone |
|
| Fax |
|
| Email |
drrohitshetty@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vardhan Bunga |
| Designation |
Senior Clinical Site Specialist |
| Affiliation |
Alcon laboratories India Pvt Ltd |
| Address |
room 01, Clinical development department Godrej Woodsman Estate Rmz Azure
It Complex 9th 10th and 11th, Bellary Rd Hebbal Bengaluru
Bangalore
KARNATAKA
560092
India |
| Phone |
|
| Fax |
|
| Email |
vardhan.bunga@alcon.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arindam Dey |
| Designation |
Head-CDMA |
| Affiliation |
Alcon laboratories India Pvt Ltd |
| Address |
Room 02 , Medical affairs & Clinical development department, Godrej Woodsman Estate Rmz Azure
It Complex 9th 10th and 11th Bellary Rd Hebbal Bengaluru
Bangalore
KARNATAKA
560092
India |
| Phone |
|
| Fax |
|
| Email |
arindam.dey@alcon.com |
|
|
Source of Monetary or Material Support
|
| Alcon Laboratories Inc
6201 South Freeway Fort Worth, TX 76134-2099 USA
|
|
|
Primary Sponsor
|
| Name |
Alcon Laboratories Inc |
| Address |
6201 South Freeway Fort Worth, TX 76134-2099 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NA |
Not applicable |
|
|
Countries of Recruitment
|
Germany
India
Turkey |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rohit Shetty |
Narayana Nethralaya |
Main Centre:
121/C Chord Rd Near Iskcon Temple, 1st R Block Rajajinagar Bengaluru Karnataka 560010
Bangalore
KARNATAKA |
00919632419350
drrohitshetty@yahoo.com |
| Dr Rohit Shetty |
Narayana Nethralaya 2 |
Satellite Center:
Narayana Health City NarayanHrudayalaya Campus 258/A Bommasandra Hosur Rd Electronic City Bengaluru Karnataka 560099
Bangalore
KARNATAKA |
00919632419350
drrohitshetty@yahoo.com |
| Dr D Ramamurthy |
The Eye Foundation eye hospital |
582-A Diwan Bahadur Rd
R.S. Puram
641002, India
Coimbatore
TAMIL NADU |
004224242000
drramamurthy@theeyefoundation.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics committee of the Eye Foundation |
Approved |
| Narayana Nethralaya Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not appliacble |
Not applicable |
| Intervention |
WaveLight UV-Femtosecond
Laser System, Model 1026
(UV-FS laser) |
Investigational ultraviolet femtosecond laser (UV fs-Laser) for providing refractive surgery: one corneal flap creation prior to LASIK for each subject. Corneal flap |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of either sex who are at least 18 years of age or older, with good ocular health, natural lens with no evidence of cataract, who meet minimum requirements for ECD, are eligible for
LASIK, and have stable refraction (as determined by defined MRSE criteria) with sphere of -1.00 to -8.0 D and cylinder < 3.0 D in the study eye are eligible to participate in the study. |
|
| ExclusionCriteria |
| Details |
Subjects with contraindicated systemic disease or ocular conditions, including dry eye, treatment with a contraindicated medication, or with predicted postoperative stromal bed thickness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean difference between achieved average central corneal flap thickness and intended flap thickness. |
At 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Maximum deviation of average central flap thickness from flap thickness at the margins
2. Ease of flap lift assessed on 0-5 scale
3. Deviation of actual corneal flap diameter
4. Quality of corneal flap at the margin |
1. At 1 month
2. At the surgery Visit
3. At the surgery visit
4. At the surgery visit |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/06/2022 |
| Date of Study Completion (India) |
16/09/2023 |
| Date of First Enrollment (Global) |
30/06/2022 |
| Date of Study Completion (Global) |
23/02/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The WaveLight Laser demonstrated the
ability to accurately and safely cut corneal flaps as part of myopia correcting
LASIK procedures. All flaps were successfully created and lifted and no safety
concerns were identified.
|