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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/09/005012
• Date of registration: 11-09-2014
• Prospective Registration: No
• Primary sponsor: Research Foundation Nethradhama Eye Hospital
• Public title: Outcomes of tissue addition with corneal strengthening procedure for low to moderate degrees of keratoconus
• Scientific title: Clinical outcomes of FILI(Femtoseconlaser Intrastromal Lenticular Implantation)with accelerated cross linkage for low to moderate degrees of keratoconus - FILI KCN
• Date of first enrolment: 01-09-2014
• Target sample size: 30
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10061
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Sri Ganesh
• Affiliation: Nethradhama Superspeciality Eye Hospital

• Name: Dr Sheetal Brar
• Affiliation: Nethradhama Superspeciality Eye Hospital

Key inclusion & exclusion 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: • Age >40 years

• Advanced keratoconus with apical scarring

• Steep K values <58 D

• Thinnest pachymetery <400 µm

• 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.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Patients with early or moderate keratoconus with documented proof of progression

Intervention(s)

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 corneal tissue(tested for HIV, HCV, HBV, obtained from patients undergoing ReLEx SMILE for myopia correction ) along with accelerated cross linkage using 0.1% riboflavin dye injection in pocket and exposure to UV radiation at 30mW/cm2 for 3.3 minutes
Control Intervention1: nil: nil

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

NIL

Source(s) of Monetary Support

Research Foundation , Nethradhama Eye Hospital

Ethics review

Status: Approved
Approval date: 20/08/2014
Contact:

Nethradhama Superspeciality Eye Hospital