Cross-linking for Corneal Ulcers Treatment Trial

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-03-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Collagen Crosslinking for Keratoconus - a Randomized Controlled Clinical Trial

NCT01604135

Keratoconus

ACTIVE_NOT_RECRUITING PHASE3

Collagen Cross-linking in Infectious Keratitis Trial

NCT01831206

Infectious Keratitis Bacterial Keratitis Fungal Keratitis

COMPLETED PHASE2

Cross-Linking ACcéléré Iontophorèse Confocal kératocONE

NCT03429569

Keratoconus

UNKNOWN PHASE4

Assessing Patient Engagement in Keratoconus Clinical Research

NCT06288737

Keratoconus

NOT_YET_RECRUITING

Donors Predisposed by Corneal Collagen Cross-linking in Deep Lamellar Keratoplasty for the Patients With Keratoconus

NCT05905978

Keratoconus

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Corneal Ulcer Infectious Keratitis Bacterial Ulcer Fungal Ulcer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients with corneal ulcers are randomized to topical antimicrobial plus corneal crosslinking versus topical antimicrobial alone

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bacterial ulcer cross-linking

Standard of care topical treatment for bacterial ulcer plus cross-linking

Group Type EXPERIMENTAL

Corneal Cross-linking

Intervention Type PROCEDURE

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

Standard of care topical treatment for bacterial ulcer

Group Type ACTIVE_COMPARATOR

Corneal Cross-linking

Intervention Type PROCEDURE

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 cross-linking plus natamycin

Standard of care topical treatment for fungal ulcer with natamycin plus cross-linking

Group Type EXPERIMENTAL

Corneal Cross-linking

Intervention Type PROCEDURE

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.

Anti Fungal Drug

Intervention Type DRUG

Topical Amphotericin B vs Topical Natamycin

Fungal ulcer control with natamycin

Standard of care topical treatment for fungal ulcer with natamycin

Group Type ACTIVE_COMPARATOR

Corneal Cross-linking

Intervention Type PROCEDURE

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.

Anti Fungal Drug

Intervention Type DRUG

Topical Amphotericin B vs Topical Natamycin

Fungal ulcer cross-linking plus amphotericin

Standard of care topical treatment for fungal ulcer with amphotericin plus cross-linking

Group Type EXPERIMENTAL

Corneal Cross-linking

Intervention Type PROCEDURE

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.

Anti Fungal Drug

Intervention Type DRUG

Topical Amphotericin B vs Topical Natamycin

Fungal ulcer control with amphotericin

Standard of care topical treatment for fungal ulcer with amphotericin

Group Type ACTIVE_COMPARATOR

Corneal Cross-linking

Intervention Type PROCEDURE

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.

Anti Fungal Drug

Intervention Type DRUG

Topical Amphotericin B vs Topical Natamycin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Corneal 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.

Intervention Type PROCEDURE

Anti Fungal Drug

Topical Amphotericin B vs Topical Natamycin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No