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Completed

NCT Number: NCT06967376

The Role of Adjuvant Corneal Crosslinking in the Management of Infective Keratitis

This was a prospective, single centre, randomised controlled study to evaluate the clinical effectiveness of corneal collagen crosslinking as an adjuvant to antimicrobial therapy.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Research Institute of Ophthalmology, Giza, Giza Governorate, Egypt

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About this study

This randomised controlled study of forty eyes of forty patients was conducted to assess the impact of corneal collagen crosslinking in addition to antimicrobial therapy.

All forty patients presenting with infective keratitis of various aetiologies (bacterial, fungal, acanthamoeba) were screened and then randomly allocated equally to two groups (A and B). Group A patients were to be offered standard targeted anti-microbial therapy whilst group B were offered CXL in addition to the standard targeted anti-microbial therapy.

Patients were evaluated clinically for visual acuity; infection parameters and dimensions were measured on slit lamp and optical coherence tomography. Evaluations were noted at the baseline visit and subsequently on days 7, 14, and day 30 of treatment

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients presenting with infectious keratitis

Exclusion criteria

  • Infective keratitis < 1mm from limbus
  • Corneal thickness < 350μm
  • Previous herpetic eye disease
  • Expectant and nursing women

Treatment and study plan

Corneal Collagen Cross-Linking Solutions

Procedure

Topical anaesthesia was achieved using 0.4% benoxinate hydrochloride drops. Epithelium was removed up to 9 mm diameter. Corneal thickness of the area to be treated was measured (without epithelium) aiming for a starting thickness of no less than 350μm. Corneas thicker than 500μm were dehydrated to reduce thickness by using 70% Glycerol drops applied topically at intervals of 2-3 seconds for a total of five minutes. A schematic representation of PACK-CXL protocol is provided in Figure 1. Iso-osmolar riboflavin drops were instilled topically on the cornea at regular intervals of 2 minutes for a total period of 30 minutes. Thickness was also re-measured every 5 min to ensure that it remained below 500µm during instillation of riboflavin. The cornea was illuminated using a UVX, UV-A 365 nm with an irradiance of 3 mW/cm2 for 30 minutes and a total dose of 5.4 J/cm2 during which riboflavin was instilled every 2 min and corneal pachymetry performed every 5 min. PACK-CXL was performed in a 9

Topical Antimicrobial/Antifungal Medications

Drug

Initial antimicrobial therapy for both groups consisted of fortified vancomycin eye drops 50 mg/ml, fortified ceftazidime eye drops 50 mg/ml hourly, and the antifungal agent itraconazole 100 mg orally twice per day. This regimen was subject to change according to microbiology culture sensitivities and/or results.

Primary outcomes

  1. clinical response

    Time frame: At presentation; and then on day 7, day 14 and day 30 of commencing treatment

    Ulcer dimensions will be studied on slit lamp and AS-OCT.

Sponsors and collaborators

Lead sponsor

Research Institute of Ophthalmology, Egypt

Other

Registry information

Official study title

The Role of Adjuvant Cross Linking in the Management of Infective Keratitis - an OCT Based Assessment Study

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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