The primary purpose of this study is to determine if patients randomized to corneal collagen cross-linking plus medical therapy will have a lower prevalence of positive bacterial or fungal cultures immediately after the procedure than patients who received medical therapy alone. The secondary purpose of this study is to determine if patients randomized to corneal collagen cross-linking will have a better visual acuity at 3 and 12 months than patients who receive medical therapy alone.
The proposed study is a randomized controlled trial to determine whether collagen cross-linking improves outcomes in microbial keratitis. Patients presenting to the Aravind Eye Hospitals in Madurai, India for treatment of microbial keratitis will be recruited for the proposed study. Approximately 266 patients will be enrolled in the study. Subjects presenting with bacterial keratitis will be randomized to receive medical therapy plus corneal collagen cross-linking at presentation or to receive medical therapy alone. All subjects with bacterial ulcers will receive standard topical antibiotic medications as required after the procedure.
Subjects with fungal keratitis will be randomized into one of four groups:
collagen cross-linking + amphotericin;
collagen cross-linking + natamycin;
All study subjects will be followed for 12 months to evaluate response to treatment.
Investigators from the University of California, San Francisco (UCSF) will assist Aravind Eye Hospital with the study design, implementation, and analysis of the research, and will help fund the study. The investigators plan to visit Aravind to help with the study implementation. UCSF will play an important role in this study by assisting with the study design, implementation, analysis, and funding.
Corneal UlcerInfectious KeratitisBacterial UlcerFungal UlcerCorneaUlcerBacterialFungalNatamycinAmphotericin BLiposomal amphotericin B
You can join if…
Open to people ages 18 years and up
Corneal ulcer that is smear positive for either bacteria or filamentous fungus
Pinhole visual acuity worse than 20/70 in the affected eye
Not treated already with antimicrobial medications at presentation
Age over 18 years
Basic understanding of the study as determined by the physician
Commitment to return for follow up visits
You CAN'T join if...
Evidence of concomitant infection on exam or gram stain (i.e. herpes, both bacteria and acanthamoeba on gram stain)
Impending or frank perforation at recruitment
Involvement of sclera at presentation
Non-infectious or autoimmune keratitis
History of corneal transplantation or recent intraocular surgery
No light perception in the affected eye
Pinhole visual acuity worse than 20/200 in the unaffected eye
Participants who are decisionally and/or cognitively impaired
Proctor Foundation, UCSFin progress, not accepting new patients San Francisco, California, 94143, USA
Aravind Eye Hospitalsaccepting new patients Madurai, Tamil Nadu, India