Role of Anterior Segment Optical Coherence Tomography in Infectious Keratitis

Sponsor

Minia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04969640

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the role of anterior segment optical coherence tomography in follow up of infectious keratitis and assessment of response to treatment.

Condition or Disease	Intervention/Treatment	Phase
Infective Keratitis	Other: Optical coherence tomography

Detailed Description

50 patients with proven infectious keratitis clinically will be included in the study.

The following will be performed for all patients in initial visit and follow up:

Slit lamp examination and photography.
Visual acuity assessment.
Anterior segment optical coherence tomography.

The central corneal thickness (CCT) (extracted from pachymetry map),
Minimal corneal thickness (MCT) (extracted from pachymetry map)
Corneal thickness at the site of the lesion (CTL) (extracted from pachymetry map or the sum of STL+ CETL)
Stromal thickness at the center of the lesion (STL) stromal lesion (extracted from stromal map)
Corneal epithelial thickness over the stromal lesion (CETL) at the center of the lesion (extracted from epithelial map)

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Role of Anterior Segment Optical Coherence Tomography in Staging and Evaluation of Treatment Response in Infectious Keratitis

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
infective keratitis 50 cases with infectious keratitis (any age) either received medical treatment or not, attending to our department will be included in the study.	Other: Optical coherence tomography Anterior segment optical coherence tomography examination of corneas with infective keratitis

Arm

Intervention/Treatment

infective keratitis

50 cases with infectious keratitis (any age) either received medical treatment or not, attending to our department will be included in the study.

Other: Optical coherence tomography

Anterior segment optical coherence tomography examination of corneas with infective keratitis

Outcome Measures

Primary Outcome Measures

criteria of lesion on optical coherence tomography [1 month]
Localiztion, depth of infiltration area in microns
width of lesion on optical coherence tomography [1 month]
width of infiltration in microns

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Any case with infectious keratitis (any age) either received medical treatment or not, attending to our department will be included in the study.

Exclusion Criteria:

Cases with healed infectious keratitis.
Cases presented from the start with severe corneal affection and melting.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Minya		Egypt

Sponsors and Collaborators

Minia University

Investigators

Principal Investigator: Ahmed Abdelghany, ASS PROF, Minia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahemd Abdelghany, Assistant professor, Minia University

ClinicalTrials.gov Identifier:

NCT04969640

Other Study ID Numbers:

43:6/2021

First Posted:

Jul 21, 2021

Last Update Posted:

Jul 21, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Keratitis

Study Results

No Results Posted as of Jul 21, 2021