| 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
|
|
|
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
|
|
|
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. |