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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02570321
Other study ID # 14-14918
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 2015
Est. completion date November 2020

Study information

Verified date November 2019
Source University of California, San Francisco
Contact Jennifer R Rose-Nussbaumer, MD
Phone 415-502-2666
Email Jennifer.Rose-Nussbaumer@ucsf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 266
Est. completion date November 2020
Est. primary completion date November 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
Bacterial ulcer cross-linking
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
Bacterial ulcer control
For those bacterial ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for bacterial ulcers. This group will have their eyes irrigated with a balanced salt solution.
Fungal ulcer cross-linking
Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital. For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
Fungal ulcer control
Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital. For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.

Locations

Country Name City State
India Aravind Eye Hospitals Madurai Tamil Nadu
United States Proctor Foundation, UCSF San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco Aravind Eye Hospitals, India

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Microbiological cure on repeat culture 4 to 24 hours after enrollment
Secondary Best spectacle-corrected visual acuity 12 months
Secondary Scar size Measured by clinical exam 12 months
Secondary Adverse events including rate of perforation/need for therapeutic penetrating keratoplasty 12 months
Secondary Corneal thinning As measured on Pentacam 12 months
Secondary Topography As measured on Pentacam 12 months
Secondary Corneal Higher Order Aberrations As measured on Pentacam 12 months
Secondary Vision related quality of life As measured by the Indian Visual Function Questionnaire 3 months
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