Cross-linking for Corneal Ulcers Treatment Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Ocular, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/7/2018 |
| Start Date: | November 2015 |
| End Date: | November 2020 |
| Contact: | Jennifer R Rose-Nussbaumer, MD |
| Email: | Jennifer.Rose-Nussbaumer@ucsf.edu |
| Phone: | 415-502-2666 |
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.
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:
1. collagen cross-linking + amphotericin;
2. collagen cross-linking + natamycin;
3. amphotericin alone;
4. natamycin alone.
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.
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:
1. collagen cross-linking + amphotericin;
2. collagen cross-linking + natamycin;
3. amphotericin alone;
4. natamycin alone.
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.
Inclusion criteria:
- 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
Exclusion criteria:
- 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
We found this trial at
2
sites
Madurai, Tamil Nadu 625001
Principal Investigator: NV Prajna, DNB, FRC Ophth
Phone: +91 452 435 6100
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