NCT02865876

Brief Summary

The objective of this study is to evaluate the efficacy and safety of accelerated cross-linking (Avedro Inc., Waltham, USA) in the management of microbial keratitis as adjunctive therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 15, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

August 1, 2016

Last Update Submit

August 9, 2016

Conditions

Keratitis

Keywords

Infectious keratitisCross-linking

Outcome Measures

Primary Outcomes (1)

  • Healing

    Full epithelialization without evidence of infiltrates

    Three months

Secondary Outcomes (1)

  • Complications

    Three months

Study Arms (2)

Accelerated Corneal Cross-linking

EXPERIMENTAL

Cross-linking in the management of microbial keratitis is an adjunctive therapy.This procedure is conducted under sterile conditions in the operating room. Tetracaine hydrochloride 0.5% (Ponti Ofteno, Sophia, Mexico) eye drops is apply for topical anesthesia. The corneal epithelium on the edge of the ulcer is cautiously removed using a microsponge. As photosensitizer, riboflavin 0.1% (Vibex, Avedro Inc, Waltham, USA) is used for 10 minutes. After impregnation, the participant´s cornea is irradiaded with UVA-light (370 nm) using 30 mW/cm2 for 3 minutes (which corresponds to a total dose of 5.4J/cm2) with accelerated cross-linking (Avedro Inc., Waltham, USA). After procedure, conventional treatment for keratitis remains unchanged.

Procedure: Accelerated Corneal Cross-linking

Sham Accelerated Corneal Cross-linking

SHAM COMPARATOR

Placebo surgery. This procedure is conducted under sterile conditions in the operating room. Tetracaine hydrochloride 0.5% (Ponti Ofteno, Sophia, Mexico) eye drops is apply for topical anesthesia. Investigators do not perform removal of the corneal epithelium in edge of the ulcer. The researchers conducted "the impregnation phase" applying drops of saline solution for 10 minutes. After impregnation fase, a device is placed in Avedro equipment off (Avedro Inc, Waltham, USA) this device emits white light for 3 minutes. After procedure, conventional treatment for keratitis remains unchanged.

Procedure: Accelerated Corneal Cross-linking

Interventions

Accelerated Corneal Cross-linkingPROCEDURE

All participants in this group receiving conventional therapy (moxifloxacin 0,5% for bacterial keratitis or natamycin for mycotic keratitis) plus accelerated cross-linking (Avedro Inc., Waltham, USA) under topical anesthesia using 0.1% riboflavin (Vibex, Avedro Inc, Waltham, USA) for 10 minutes and irradiation 30 mW/cm2 during 3 minutes.

Accelerated Corneal Cross-linkingSham Accelerated Corneal Cross-linking

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with infectious keratitis (initial or refractory to treatment) including bacterial or mycotic keratitis with size larger than 3 mm

You may not qualify if:

  • herpetic keratitis
  • Acanthamoeba keratitis
  • pregnancy
  • endophthalmitis
  • systemic immunosuppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Oftalmologia Conde de Valenciana

Mexico City, 06800, Mexico

RECRUITING

Related Publications (7)

  • Li Z, Jhanji V, Tao X, Yu H, Chen W, Mu G. Riboflavin/ultravoilet light-mediated crosslinking for fungal keratitis. Br J Ophthalmol. 2013 May;97(5):669-71. doi: 10.1136/bjophthalmol-2012-302518. Epub 2013 Jan 26. No abstract available.

    PMID: 23355529RESULT

  • Moren H, Malmsjo M, Mortensen J, Ohrstrom A. Riboflavin and ultraviolet a collagen crosslinking of the cornea for the treatment of keratitis. Cornea. 2010 Jan;29(1):102-4. doi: 10.1097/ICO.0b013e31819c4e43.

    PMID: 19730094RESULT

  • Anwar HM, El-Danasoury AM, Hashem AN. Corneal collagen crosslinking in the treatment of infectious keratitis. Clin Ophthalmol. 2011;5:1277-80. doi: 10.2147/OPTH.S24532. Epub 2011 Sep 7.

    PMID: 21966201RESULT

  • Price MO, Tenkman LR, Schrier A, Fairchild KM, Trokel SL, Price FW Jr. Photoactivated riboflavin treatment of infectious keratitis using collagen cross-linking technology. J Refract Surg. 2012 Oct;28(10):706-13. doi: 10.3928/1081597X-20120921-06.

    PMID: 23062001RESULT

  • Alio JL, Abbouda A, Valle DD, Del Castillo JM, Fernandez JA. Corneal cross linking and infectious keratitis: a systematic review with a meta-analysis of reported cases. J Ophthalmic Inflamm Infect. 2013 May 29;3(1):47. doi: 10.1186/1869-5760-3-47.

    PMID: 23718849RESULT

  • Uddaraju M, Mascarenhas J, Das MR, Radhakrishnan N, Keenan JD, Prajna L, Prajna VN. Corneal Cross-linking as an Adjuvant Therapy in the Management of Recalcitrant Deep Stromal Fungal Keratitis: A Randomized Trial. Am J Ophthalmol. 2015 Jul;160(1):131-4.e5. doi: 10.1016/j.ajo.2015.03.024. Epub 2015 Apr 1.

    PMID: 25841317RESULT

  • Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.

    PMID: 32557558DERIVED

MeSH Terms

Conditions

Keratitis

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Enrique Graue-Hernandez, MSc

    Instituto de Oftalmologia Fundacion Conde de Valenciana

    STUDY CHAIR

Central Study Contacts

Lucero Pedro-Aguilar, MD

CONTACT

+5255880000lu.pedroaguilar@gmail.com

Aida Jimenez-Corona, PhD

CONTACT

+5255880000aidaajc@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 15, 2016

Study Start

June 1, 2015

Primary Completion

August 1, 2016

Study Completion

March 1, 2017

Last Updated

August 15, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Investigators describe demographic characteristics of the participants, such as age, gender, etiology, intervention group and the response variables, complications and corneal healing.

Locations

ME(1)