Outcomes of tissue addition with corneal strengthening procedure for low to moderate degrees of keratoconus
- Conditions
- Health Condition 1: null- Patients with early or moderate keratoconus with documented proof of progression
- Registration Number
- CTRI/2014/09/005012
- Lead Sponsor
- Research Foundation Nethradhama Eye Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 30
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
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method