NCT04383431

Brief Summary

To compare between SCXL and ACXL for treatment of infectious keratitis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 27, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

June 2, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

2.6 years

First QC Date

April 27, 2020

Last Update Submit

January 16, 2023

Conditions

Infectious Keratitis

Outcome Measures

Primary Outcomes (2)

  • Corneal healing

    Reepithelization of corneal ulcer which is measured in mm by slitlamp examination

    3 months

  • Corneal edema

    measurement of corneal edema by measurement of the corneal thickness in um by Optical Coherent Tomography

    3 months

Study Arms (2)

Standard CXL

EXPERIMENTAL

Standard epithelium-off CXL, 30 minutes soaking time with riboflavin, 30 minutes UVA corneal irradiation continuous mode.

Procedure: PACK-CXL

Accelerated CXL

EXPERIMENTAL

Accelerated epithelium-off CXL, 12 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation continuous mode.

Procedure: PACK-CXL

Interventions

PACK-CXLPROCEDURE

Standard epithelium-off CXL, 12 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation pulsed mode.

Accelerated CXLStandard CXL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Fungal infectious keratitis
  • bacterial infectious keratitis
  • Must be not responding to medication

You may not qualify if:

  • Viral keratitis
  • Pregnancy and lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Sohag, 82425, Egypt

Location

Study Officials

  • Mohammed Iqbal, MD. PhP

    00201068559840

    PRINCIPAL INVESTIGATOR

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
Assistant Professor of Ophthalmology

Study Record Dates

First Submitted

April 27, 2020

First Posted

May 12, 2020

Study Start

June 2, 2020

Primary Completion

January 1, 2023

Study Completion

January 15, 2023

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

Individual participant data will be allowed for sharing

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
12 months after end of study
Access Criteria
Ophthalmologists are allowed for access of data. they should email the principal investigator via dr\ m\ iqbal@yahoo.com to get the permission after reviewing the qualifications and quality of request

Locations

EG(1)