Corneal Densitometry Changes With Adenoviral SEI

May 28, 2020 updated by: Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University

Corneal Densitometry Changes With Adenoviral Keratoconjunctivitis Sub Epithelial Infiltrates

Adenoviral Sub epithelial infiltrates (SEI) affect ocular function.They lead to reduced vision, photophobia, glare, halos, and foreign body sensation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

first group of patients were treated with 0.03 % tacrolimus ointment twice daily for 6 months.S econd group underwent transepithelial PTK for subepithelial infiltrates. Baseline and post-treatment full ophthalmic examination was done.

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

60 patients with adenoviral SEI

Description

Inclusion Criteria:

  • adenoviral SEI

Exclusion Criteria:

  • Other corneal diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tacrolimus
Patients were treated with 0.03 % tacrolimus ointment twice daily for 6 months.
Drug: Tacrolimus ointment
Patients were treated with 0.03 % tacrolimus ointment twice daily for 6 months.
Other Names:
  • Protopic ointment
Phototherapeutic Keratectomy
Patients underwent transepithelial PTK for subepithelial infiltrates.
Procedure: phototherapeutic keratectomy
Patients underwent transepithelial PTK for subepithelial infiltrates.
Control
patients received only artificial tears eyedrop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of corneal densitometry
Time Frame: 6 months
Sub epithelial infiltrates was examined with the densitometry programme of the Pentacam (Fa. Oculus,Weimar, Germany)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: TAREK R ELHAMAKY, Benha university faculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 15, 2020

Study Registration Dates

First Submitted

February 11, 2020

First Submitted That Met QC Criteria

February 11, 2020

First Posted (Actual)

February 13, 2020

Study Record Updates

Last Update Posted (Actual)

May 29, 2020

Last Update Submitted That Met QC Criteria

May 28, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hamaky5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Corneal Disease

Clinical Trials on Tacrolimus ointment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe