Intrastromal Injection of Fluconazole in Treatment of Fungal Keratitis

NCT07557966 | Completed

• 1 other identifier: 35010/10/21
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety; Efficacy; Intrastromal Injection; Fluconazole; Treatment; Fungal Keratitis

Outcome Measures

Primary Outcomes (1)

• Best-corrected visual acuity

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

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

Secondary Outcomes (2)

• Uncorrected visual acuity

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

• Duration of healing

  6 weeks post-procedure

Study Arms (2)

Group A

EXPERIMENTAL

Eyes that received treatment as topical fluconazole eye drops

Drug: Topical fluconazole eye drops

Group B

EXPERIMENTAL

Eyes that received treatment as intrastromal injection of fluconazole.

Drug: Intrastromal injection of fluconazole

Interventions

Topical fluconazole eye drops DRUG

Eyes that received treatment as topical fluconazole eye drops

Group A

Intrastromal injection of fluconazole DRUG

Eyes that received treatment as intrastromal injection of fluconazole.

Group B

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Ophthalmology Department, Faculty of Medicine, Tanta University, Tanta, Egypt

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: January 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)