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CTRI Number  CTRI/2020/07/026735 [Registered on: 22/07/2020] Trial Registered Prospectively
Last Modified On: 14/06/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Treatment for nearsightedness  
Scientific Title of Study   Feasibility study of the UV-Femtosecond Laser Assisted Lenticular Extraction  
Trial Acronym  N/A 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohit Shetty  
Designation  Vice Chairman, Consultant-Cornea and Refractive  
Affiliation  Narayana Nethralaya (NN1) 
Address  Narayana Nethralaya, 121/C, Chord Road, Rajaji Nagar Bangalore India

Bangalore
KARNATAKA
560010
India 
Phone    
Fax    
Email  drrohitshetty@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arindam Dey 
Designation  Head Clinical Development and Medical Affairs 
Affiliation  Alcon Laboratories India Pvt Ltd 
Address  3rd Floor, Crescent 4, Prestige Shantiniketan, Whitefield,

Bangalore
KARNATAKA
500048
India 
Phone  08040064683  
Fax    
Email  arindam.dey@alcon.com  
 
Details of Contact Person
Public Query  
Name  Dr Arindam Dey 
Designation  Head Clinical Development and Medical Affairs 
Affiliation  Alcon Laboratories India Pvt Ltd 
Address  3rd Floor, Crescent 4, Prestige Shantiniketan, Whitefield,

Bangalore
KARNATAKA
500048
India 
Phone  08040064683  
Fax    
Email  arindam.dey@alcon.com  
 
Source of Monetary or Material Support  
Alcon laboratories India pvt Ltd 
 
Primary Sponsor  
Name  Alcon laboratories India pvt Ltd 
Address  3rd Floor, Crescent 4, Prestige Shantiniketan, Whitefield, Bangalore, Karnataka 560048, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Turkey  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR ROHIT SHETTY  NARAYANA NETHRALAYA (NN1)  121/C Chord road, 1 R Block Rajaji Nagar, 3rd Floor, Banaglore, 560010, IN
Bangalore
KARNATAKA 		 09611102568

drrohitshetty@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Nethralaya Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H521||Myopia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  WaveLight UV-Femtosecond Laser System, Model 1026 (UV-FS laser)  Refractive correction for myopia (using a UV-FS laser to create an intrastromal Lenticule in the cornea which is then extracted ) - The device may only be used for one treatment. There is an initial incision, and an optional 2nd incision - The amount of time the laser power is active during each treatment is approximately 10 seconds  
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  - Subject must be able to understand and sign an IRB/IEC approved Informed Consent form.

- Willing and able to attend all scheduled study visits as required per protocol

- Myopia with sphere of -0.50 to -10.0 D cylinder <1.00 D (MRSE within -0.50 to -10.0 D)

- Other protocol defined inclusion criteria may apply  
 
ExclusionCriteria 
Details  - Women of childbearing potential, defined as all women who are physiologically capable of becoming pregnant and who are not postmenopausal for at least 1 year or are less than 6 weeks since sterilization, are excluded from participation if any of the following apply:

a. they are currently pregnant,
b. have a positive UPT result at Screening,
c. intend to become pregnant during the study period,
d. are breast-feeding.
Subjects who become pregnant during the study will not be discontinued; however, data will be excluded from the effectiveness analyses because pregnancy can alter refraction and visual acuity results


- Study eye unable to focus for imaging and/or treatment

- Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study as clinically assessed by the Investigator (including history
of Herpes Simplex)

- Current use of medications with known ocular side effects and photosensitivity, including but not limited to: steroids, antimetabolites, Isotretinoin (Accutane®), Amiodarone hydrochloride (Cordarone),or Hydroxychloroquine (Plaquenil), Tetracyclincs, Nalidixic Acids, and Fluoroquinolones

- Other protocol specified exclusion criteria may apply  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Extraction of lenticule
(-0.5 to -10.0 D)

2. Presence of optical treatment zone corneal haze (slit-lamp examination)

3. Change in ECD between pre-op and post-op

4. Presence of Lens Opacification (slit-lamp examination)

5. Presence of disruption in the integrity of retinal layers (OCT)
 		 1. At Surgery visit


2. At 1 month and 6 months


3. At 1 month and 6 months

4. At 1 month and 6 months


5. At 1 month and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable   Not applicable  
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2020 
Date of Study Completion (India) 06/06/2023 
Date of First Enrollment (Global)  15/09/2020 
Date of Study Completion (Global) 24/02/2022 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The purpose of this study is to obtain additional safety and feasibility data on the UV-Femto procedure. Currently, a similar procedure for refractive surgery is approved for treating myopia by removal of a corneal lenticule. However, the approved procedure utilizes IR light to create corneal incisions and the intrastromal lenticule, while UV-FS laser has the advantage of using UV light with a significantly lower pulse energy as compared with standard IR femtosecond lasers. The UV-FS laser has shown preliminary safety and feasibility in removal of lenticules in a high myopic treatment in a previous study. 
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