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Outcomes of tissue addition with corneal strengthening procedure for low to moderate degrees of keratoconus

Clinical outcomes of FILI(Femtoseconlaser Intrastromal Lenticular Implantation)with accelerated cross linkage for low to moderate degrees of keratoconus - FILI KCN

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/09/005012
Enrollment
30
Registered
2014-09-11
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- Patients with early or moderate keratoconus with documented proof of progression

Interventions

Intervention1: tissue addition and collagen cross linking for keratoconus: A stromal pocket will be made into patients cornea with femtolaser followed by insertion of cryopreserved corneal donor corn

Sponsors

Research Foundation Nethradhama Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ï?? Mild to moderate degrees of keratoconus ï?? Documented evidence of progressive keratoconus ï?? Best Spectacle Corrected Visual Acuity (BSCVA) > 6/24 ï?? Age ( 21- 40 years ) ï?? Intolerance to RGP /Rose K/ Scleral lenses ï?? Central cone on topography 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: • Age >40 years • Advanced keratoconus with apical scarring • Steep K values • Thinnest pachymetery • Minimum midperipheral pachymetery of 350µm or more • Endothelial Cell count > 1500 cells/mm² • Eccentric cone distribution on topography • Active atopic keratoconjunctivitis / Vernal catarrh • Evidence of ocular diseases like severe meibomian gland diseases, herpetic keratitis, uvietis, glaucoma. • Corneal ectasia due to previous laser ablative surgery(LASIK/ PRK) • H/o Riboflavin allergy • Dry eye status-Schirmerâ??s I value less than 10 mm • Long term ocular medication like β blockers. • Concurrent use of systemic medication likely to affect wound healing like corticosteroids or antimetabolites. • H/o immunocompromised state /pregnancy / nursing mothers . • Patients with unrealistic expectations.

Design outcomes

Primary

MeasureTime frame
improvement in Uncorrected and Best corrected visual acuity and corneal stabilityTimepoint: day 1, day 15, 3 months and 6 months—

Secondary

MeasureTime frame
Topography, ASOCT, Aberrations, Dry eyeTimepoint: 15 days, 3 months, 6 months—

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