NCT04267991

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

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

Study Start

First participant enrolled

April 1, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2020

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

2 years

First QC Date

February 11, 2020

Last Update Submit

May 28, 2020

Conditions

Corneal Disease

Keywords

adenoviralinfiltratesPTKtacrolimus

Outcome Measures

Primary Outcomes (1)

  • changes of corneal densitometry

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

    6 months

Study Arms (3)

Tacrolimus

Patients were treated with 0.03 % tacrolimus ointment twice daily for 6 months.

Drug: Tacrolimus ointment

Phototherapeutic Keratectomy

Patients underwent transepithelial PTK for subepithelial infiltrates.

Procedure: phototherapeutic keratectomy

Control

patients received only artificial tears eyedrop

Interventions

Tacrolimus ointmentDRUG

Patients were treated with 0.03 % tacrolimus ointment twice daily for 6 months.

Also known as: Protopic ointment
Tacrolimus
phototherapeutic keratectomyPROCEDURE

Patients underwent transepithelial PTK for subepithelial infiltrates.

Phototherapeutic Keratectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

60 patients with adenoviral SEI

You may qualify if:

  • adenoviral SEI

You may not qualify if:

  • Other corneal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INMC

Abu Dhabi, 46266, United Arab Emirates

Location

Related Publications (1)

  • Elhamaky TR. Pentacam corneal densitometry-guided treatment of adenoviral corneal subepithelial infiltrates: a comparative study between transepithelial phototherapeutic keratectomy and topical tacrolimus. Int Ophthalmol. 2021 Jan;41(1):67-77. doi: 10.1007/s10792-020-01553-8. Epub 2020 Aug 27.

    PMID: 32852646DERIVED

MeSH Terms

Conditions

Corneal DiseasesAdenoviridae Infections

Condition Hierarchy (Ancestors)

Eye DiseasesDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • TAREK R ELHAMAKY

    Benha university faculty of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 13, 2020

Study Start

April 1, 2018

Primary Completion

April 1, 2020

Study Completion

April 15, 2020

Last Updated

May 29, 2020

Record last verified: 2020-05

Locations

AE(1)