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Cold preservation of corneal tissue removed during laser correction of short sight

CRYOPRESERVATION OF EXTRACTED CORNEAL LENTICULES AFTER RELEX SMILE FOR HUMAN USE - CrReLEx

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/01/004331
Enrollment
10
Registered
2014-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Healthy patients with hypermetropia with amblyopia or aphakia

Interventions

Intervention1: to study the safety, viabilty , refractive efficacy and outcomes of cryopreserved corneal lenticules (after ReLEx SMILE surgery) for treatment of hypermetropia with amblyopia in otherwi

Sponsors

Nethradhama Research Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: •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-SCHIRMERâ??S 2 TEST VALUE LESS THAN 10 MM •LONG TERM OCULAR MEDICATION LIKE Î? 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.

Design outcomes

Primary

MeasureTime frame
Safety and refractive outcome of tissue addition (cryopreserved donor lenticule ) in the treatment of hypermetropia and aphakiaTimepoint: patients will be followed up at 1st day, 15th day, 1 month, 3 month and 6 months after surgery—

Secondary

MeasureTime frame
refractive and clinical outcomes - uncorrected and best corrected visual acuity, contrast sensitivity, aberrations , endothelial changes , topographic changesTimepoint: 1 day, 15th day, 1 month, 3 month, amd 6 month after surgery—

Countries

India

Contacts

Public ContactDr Sheetal Brar

Nethradhama Superspeciality Eye Hospital, Bangalore

brar_sheetal@yahoo.co.in9591002092

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 7, 2026