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Completed

NCT Number: NCT07557966

Intrastromal Injection of Fluconazole in Treatment of Fungal Keratitis

This study aimed to evaluate the Safety and the Effectiveness of Intrastromal Injection of Fluconazole in The Treatment of Fungal Keratitis.

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Key information

Conditions

Safety Efficacy Fluconazole Fungal Keratitis Intrastromal Injection Treatment

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

Fungal keratitis is one of the most challenging types of infectious keratitis. It now accounts for approximately 50% of infectious corneal diseases, and corneal blindness has become the second leading cause of blindness in developing countries.

The potentially poor prognosis may be due to a delay in diagnosis and / or to limited effective antifungal agents that leads to decrease visual acuity and blindness.

Fluconazole is mainly a fungistatic drug with broad spectrum activity as it is effective against Yeast & Dermatophytes (Candida, Cryptococcus neoformans & Aspergillus species) Fluconazole is stable and a water-soluble small molecule with high bioavailability and low toxicity.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed both clinically and laboratory as fungal keratitis.
  • Fungal cultures should be sensitive to fluconazole.

Exclusion criteria

  • Thin cornea.
  • Decmatocele.
  • Necrotic or perforated corneal ulcers.
  • Other types of keratitis (bacterial or viral).
  • Fungal cultures resistant to fluconazole.
  • Patients on immune-suppressants drugs.
  • Silicon oil filled eyes.
  • Previous ocular surgery e.g keratoplasty.

Treatment and study plan

Topical fluconazole eye drops

Drug

Eyes that received treatment as topical fluconazole eye drops

Intrastromal injection of fluconazole

Drug

Eyes that received treatment as intrastromal injection of fluconazole.

Primary outcomes

  1. Best-corrected visual acuity

    Time frame: Every three days until complete healing (Up to 6 weeks)

    Best-corrected visual acuity (BCVA) was recorded and described by LogMAR notation.

Secondary outcomes

  1. Uncorrected visual acuity

    Time frame: Every three days until complete healing (Up to 6 weeks)

    Uncorrected visual acuity was recorded and described by LogMAR notation.

  2. Duration of healing

    Time frame: 6 weeks post-procedure

    Duration of healing was recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Assessment of the Safety and Efficacy of Intrastromal Injection of Fluconazole in Treatment of Fungal Keratitis

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

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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