Corneal Densitometry Changes With Adenoviral SEI

Sponsor
Benha University (Other)
Overall Status
Completed
CT.gov ID
NCT04267991
Collaborator
(none)
63
1
24.5
2.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Tacrolimus ointment
  • Procedure: phototherapeutic keratectomy

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 Design

Study Type:
Observational
Actual Enrollment :
63 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Corneal Densitometry Changes With Adenoviral Keratoconjunctivitis Sub Epithelial Infiltrates
Actual Study Start Date :
Apr 1, 2018
Actual Primary Completion Date :
Apr 1, 2020
Actual Study Completion Date :
Apr 15, 2020

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

    1. changes of corneal densitometry [6 months]

      Sub epithelial infiltrates was examined with the densitometry programme of the Pentacam (Fa. Oculus,Weimar, Germany)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • adenoviral SEI
    Exclusion Criteria:
    • Other corneal diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 INMC Abu Dhabi United Arab Emirates 46266

    Sponsors and Collaborators

    • Benha University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tarek Roshdy mohamed Mahgoub ELhamaky, Lecturer, Benha University
    ClinicalTrials.gov Identifier:
    NCT04267991
    Other Study ID Numbers:
    • Hamaky5
    First Posted:
    Feb 13, 2020
    Last Update Posted:
    May 29, 2020
    Last Verified:
    May 1, 2020
    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
    Keywords provided by Tarek Roshdy mohamed Mahgoub ELhamaky, Lecturer, Benha University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 29, 2020