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New treatment for long sight by tissue addition

FILI (Femtosecondlaser Intrastromal Lenticular Implantation): a new treatment option for hypermetropia. - FILI

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/04/004536
Enrollment
10
Registered
2014-04-09
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 individuals with unilateral hypermetropia with amblyopia

Interventions

Intervention1: Implantation of donor lenticule into patients cornea: Lenticules will be extracted and cryopreserved from patients undergoing ReLEx SMILE surgery and after obtaining informed consent a

Sponsors

Nethradhama Research Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ï?? HYPERMETROPIA ( > 3D SPHERICAL EQUIVALENT) WITH AMBLYOPIA ï?? APHAKIA ï?? AGE ABOVE 21 YEARS AND LESS THAN 65 YEARS. ï?? SOFT CONTACT LENS DISCONTINUED FOR MINIMUM 1 WEEK AND RIGID GAS PERMEABLE CONTACT LENS DISCONTINUED FOR MINIMUM 3 WEEKS ï?? ABILITY TO UNDERSTAND AND WILLINGNESS TO SIGN INFORMED CONSENT ï?? 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
TO EVALUATE FILI( FEMTOSECOND INTRASTROMAL LENTICULAR IMPLANTATION) FOR TREATMENT OF HYPERMETROPIA/APHAKIA FOR: SAFETY, VISUAL AND REFRACTIVE OUTCOMES Timepoint: Day 1, day 15, 1 month, 3 month post op

Secondary

MeasureTime frame
CORNEAL TOPOGRAPHY ABERROMETRY CONTRAST SENSITIVITY(F.A.C.T.) SPECULAR MICROSCOPY PATIENT SATISFACTION Timepoint: Day 1, day 15, 1 month, 3 month post op

Countries

India

Contacts

Public ContactDr Sri Ganesh

Nethradhama Superspeciality Eye Hospital

brar_sheetal@yahoo.co.in9591002092

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026