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CTRI Number  CTRI/2014/01/004331 [Registered on: 22/01/2014] Trial Registered Retrospectively
Last Modified On: 04/09/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Cold preservation of corneal tissue removed during laser correction of short sight  
Scientific Title of Study   CRYOPRESERVATION OF EXTRACTED CORNEAL LENTICULES AFTER RELEX SMILE FOR HUMAN USE 
Trial Acronym  CrReLEx 
Secondary IDs if Any  
Secondary ID  Identifier 
2013/44  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sri Ganesh 
Designation  Chairman Medical Director 
Affiliation  Nethradhama Superspeciality Eye Hospital 
Address  c/o Nethradhama superspeciality eye hospital No 256/14, kanakapura main road Jayanagar 7 th block Bangalore 560082
Nethradhama superspeciality eye hospital No 256/14, kanakapura main road Jayanagar 7 th block Bangalore 560082
Bangalore
KARNATAKA
560082
India 
Phone  9845129740  
Fax    
Email  phacomaverick@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sheetal Brar 
Designation  Senior Resident 
Affiliation  Nethradhama Superspeciality Eye Hospital, Bangalore 
Address  c/o Nethradhama superspeciality eye hospital No 256/14, kanakapura main road Jayanagar 7 th block Bangalore 560082
c/o Nethradhama superspeciality eye hospital No 256/14, kanakapura main road Jayanagar 7 th block Bangalore 560082
Bangalore
KARNATAKA
560082
India 
Phone  9591002092  
Fax    
Email  brar_sheetal@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sheetal Brar 
Designation  Senior Resident 
Affiliation  Nethradhama Superspeciality Eye Hospital, Bangalore 
Address  c/o Nethradhama superspeciality eye hospital No 256/14, kanakapura main road Jayanagar 7 th block Bangalore 560082
c/o Nethradhama superspeciality eye hospital No 256/14, kanakapura main road Jayanagar 7 th block Bangalore 560082
Bangalore
KARNATAKA
560082
India 
Phone  9591002092  
Fax    
Email  brar_sheetal@yahoo.co.in  
 
Source of Monetary or Material Support  
Research Foundation, Nethradhama Superspeciality Eye Hospital, Bangalore 
 
Primary Sponsor  
Name  Nethradhama Research Foundation 
Address  c/o Nethradhama superspeciality eye hospital No 256/14, kanakapura main road Jayanagar 7 th block Bangalore 560082  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Sheetal Brar  Nethradhama Superspeciality Eye Hospital, Bangalore  Phacorefractive department, 2nd floor, OPD Block Nethradhama superspeciality eye hospital No 256/14, kanakapura main road Jayanagar 7 th block Bangalore 560082
Bangalore
KARNATAKA 
9591002092

brar_sheetal@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nethradhama Eye Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Healthy patients with hypermetropia with amblyopia or aphakia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  to study the safety, viabilty , refractive efficacy and outcomes of cryopreserved corneal lenticules (after ReLEx SMILE surgery) for treatment of hypermetropia with amblyopia in otherwise healthy patients through a procedure called FILI- Femtosecondlaser Intrastromal Lenticular Implantation.  Corneal lenticule is extracted from patients undergoing ReLEx SMILE procedure for myopia correction and it is then cryopresrved after obtaining informed consent and serological testing for HIV, HBV, HCV and Syphilis. This lenticule is then implanted in a patient having hypermetropia with amblyopia by creating POCKET in their corneas with femtosecond laser and after obtaining informed consent.This procedure is called FILI- Femtosecondlaser Intrastromal Lenticular Implantation.Post op topical steroids will be prescribed for a period of 3 months in tapering doses. patients will be followed up at 1, 15, 1 month, 3 month and 6 month after surgery for clinical and refractive outcomes. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.HYPERMETROPIA (> 3D SPHERICAL EQUIVALENT) WITH AMBLYOPIA
2. APHAKIA
3. AGE ABOVE 21 YEARS AND LESS THAN 65 YEARS.

4.ABILITY TO UNDERSTAND AND WILLINGNESS TO SIGN INFORMED CONSENT
5. WILLINGNESS TO PARTICIPATE IN FOLLOW UP VISITS
 
 
ExclusionCriteria 
Details  •EVIDENCE OF OCULAR DISEASES LIKE SEVERE MEIBOMIAN GLAND DISEASES, HERPETIC KERATITIS, UVIETIS, GLAUCOMA.
•VISUALLY SIGNIFICANT CATARACT, RETINAL DISEASES LIKE RETINAL DYSTROPHIES OR DIABETIC RETINOPATHY.
•CYLINDRICAL POWER >1D.

•ANY PATHOLOGIES OF CORNEA LIKE CORNEAL DYSTROPHIES , KERATOCONUS,ANY H/O CORNEAL TRAUMA OR SURGERY WITHIN FLAP ZONE


•DRY EYE STATUS-SCHIRMER’S 2 TEST VALUE LESS THAN 10 MM

•LONG TERM OCULAR MEDICATION LIKE Β BLOCKERS.
•TAKING ANY SYSTEMIC MEDICATION LIKELY TO AFFECT WOUND HEALING LIKE CORTICOSTEROIDS OR ANTIMETABOLITES.

•H/O IMMUNOCOMPROMISED STATE OR PREGNANCY OR NURSING MOTHERS .

•PATIENTS WITH UNREALISTIC EXPECTATIONS.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Safety and refractive outcome of tissue addition (cryopreserved donor lenticule ) in the treatment of hypermetropia and aphakia  patients will be followed up at 1st day, 15th day, 1 month, 3 month and 6 months after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
refractive and clinical outcomes - uncorrected and best corrected visual acuity, contrast sensitivity, aberrations , endothelial changes , topographic changes  1 day, 15th day, 1 month, 3 month, amd 6 month after surgery 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Primary purpose- To study the viability, safety, refractive efficacy and outcomes of cryopreserved donor lenticules obtained after ReLEx SMILE procedure ,for the correction of hypermetropia and aphakia in otherwise healthy patients.
Description of the hypothesis and methodology- ReLEx SMILE is a technique for the correction of myopia(short sightedness) whereby a lenticule is created in the patients cornea using the visumax femtosecond laser and subsequently removed through a 2mm incision. the technique is considered safe and effective and offers multiple advantages over conventional LASIK procedure which involves creation of  flap and sunsequent ablation of corneal tissue underneath the flap. Since SMILE is a flapless technique it does not have disadvantages of flap dislocation , infection , post operative dry eye etc. 
The refractive lenticule which is removed after ReLEx SMILE procedure can be stored in cryopreservation and has been shown to remain viable for future use(study quoted). It can be used for the treatment of hypermetropic patients(far sightedness) by creating a pocket in their cornea with femtosecond laser and implanting this donor lenticule (which is matched for the refractive power). Before implanting the tissue into a patient, we shall be doing the serology test for HIV, HBV, HCV, Syphilis of the donor patient and a proper consent will be obtained from the donor for preserving their lenticules for use in other  patient. This technique is proposed to be a safer and effective alternative for hypermetropia correction compared to LASIK for hypermetropia, since it maintains the prolate shape of the cornea by additing tissue in the midperiphery  as against LASIK, which involves removal of tissue in midperiphery and creating a hyper prolate(abnormal) shape of cornea leading to aberrations and regression over a period of time. other advantages- it is a completely reversible procedure. Lenticule can be removed in the event of any adverse reaction if any. Chances of rejection are also extremely low, as the lenticule is a stromal tissue, which is mainly collagen tissue, and has the least antigens
Patients will be followed up at the periods of day 1, day 15, 1 month, 3 months and 6 months post operatively  and studied for clinical outcomes like visual acuity, slit lamp examination, Anterior segment OCT, specular microscopy, contrast sensitivity , aberrations and any adverse reaction.
 
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