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CTRI Number  CTRI/2010/091/000685 [Registered on: 19/07/2010]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Single Arm Study 
Public Title of Study   Clinical investigation of the femtosecond laser system for the refractive correction of hyperopic eyes by means of lenticule extraction. 
Scientific Title of Study   Clinical investigation of the femtosecond laser system for the refractive correction of hyperopic eyes by means of lenticule extraction. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Rupal Shah 
Designation   
Affiliation   
Address  303, Siddharth, R.C. Dutt Road
Alkapuri
Vadodara
GUJARAT
390 007
India 
Phone  0265 3058603  
Fax  0265 3058600  
Email  rupal@newvisionindia.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Rupal Shah 
Designation   
Affiliation   
Address  303, Siddharth, R.C. Dutt Road
Alkapuri
Vadodara
GUJARAT
390 007
India 
Phone  0265 3058603  
Fax  0265 3058600  
Email  rupal@newvisionindia.com  
 
Details of Contact Person
Public Query  
Name  Mr. Akash Bhavsar 
Designation   
Affiliation   
Address  B-501, Krishna Complex,Opp. Devashish School,Nr. Rajpath Club
S.G. Highway
Ahmadabad
GUJARAT
380 054
India 
Phone  +91-9898090605  
Fax  079-40054113  
Email  ab@investigatorsforum.net  
 
Source of Monetary or Material Support  
New Vision Laser Centers (Rajkot) Pvt. Ltd. 203, Embassy Building, Jawahar Road, Opp. Jubilee Baug, Rajkot 360 001. Gujarat,India Ph: (0281) 2240241, 2240239 Fax: (0281) 2240239  
 
Primary Sponsor  
Name  Mr. Samir Shah New Vision Laser Centers (Rajkot) Pvt. Ltd. 203, Embassy Building, Jawahar Road, Opp. Jubilee Baug, Rajkot 360 001.Gujarat, India. Ph: (0281) 2240241, 2240239 Fax: (0281) 2240239  
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Rupal Shah  New Vision Laser Center  303, Siddharth, R.C. Dutt Road,Alkapuri-390 007
Vadodara
GUJARAT 		 0265 3058603
0265 3058600
rupal@newvisionindia.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IBIOME-IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Refractive correction of Hyperopic eyes.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  femtosecond laser system  NA 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  Older than 21 Central corneal thickness > 500 urn and calculated residual stroma thickness > 250 urn Normal cornea topography No prior refractive surgery The patients commit themselves to taking part in the post-surgery examinations planned for the clinical investigation. Patients who wear contact lenses should stop wearing their lenses 4 weeks before the preliminary examination in the case of hard lenses and 2 weeks before in the case of soft lenses. Patients should exhibit one of the following vision defects: a)Subjective hyperopia (SPH) of up to +8 D of natural cause, measured at the cornea level b)Subjective astigmatism (CYL) of up to 5 D, natural cause c)Spherocylindrical combinations of up to +8 D SEQ There are no restrictions regarding gender or race. The patients must sign a patient consent declaration which explains the conditions under which they take part in the clinical investigation, the alternative treatment types and the risks.  
 
ExclusionCriteria 
Details  Patients who cannot lie flat and still for a short period Patients who are not capable of making themselves understood or giving their consent Known allergies or intolerances to medications administered Immunosuppressed patients, e.g. patients with AIDS or autoimmune disorders Treatment with medication which influence wound healing, e.g. steroids, antimetabolites and immunosuppressors Diagnosis of diabetes or connective tissue disorders Pregnant and breastfeeding women, plus women who are planning a pregnancy in the period of the clinical study Unstable refraction Any residual, recurrent, or acute ocular disease or abnormality of the eye to be treated. Cataract Suspected glaucoma or intraocular pressure >21mm Hg Disease of the cornea Disease involving thinning of the cornea such as keratoconus and pellucid marginal degeneration Dystrophy of basement membrane Exudative macular degeneration Infections and inflammations of the eye, e.g. uveitis, iritis, blepharitis Existing, recurrent, or acute ocular disease or abnormality of the eye to be treated. Existing corneal implant Lesion or scarring of the cornea Herpes simplex or herpes zoster keratitis Dry eyes Participation in other ophthalmic studies  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.The change in refraction in the periods between 12 and 24 weeks and between 24 and 36 weeks after the surgery determined to assess the stability of the treatment. 2.The deviation from the target refraction per eye is used to determine the reproducibility of the procedure. At least 50% of the eyes should meet the target refraction within ± 0.5 D and 75% within 1 D. A variability of ± 0.25 D is within the limits of biological variability and the measurement accuracy of the procedure.   12 and 24 weeks and between 24 and 36 weeks.  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  03/02/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The prospective single arm non randomize clinical study to demonstrate the safety and feasibility of using the femtosecond laser system for the refractive correction of hyperopic eyes. The study will be conducted at single center in India and planned as a single group, no control group study. The primary objective is to document Improvement of uncorrected visual acuity for far sight vision (UCVA) and change in refraction in the periods between 12 and 24 weeks and between 24 and 36 weeks after the operation is determined to assess the stability of the treatment The secondary outcomes will be to determine the astigmatism of the participants before and at specified times after the operation. 
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