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CompletedNCT04267991Updated May 29, 2020

Corneal Densitometry Changes With Adenoviral SEI

An observational study in Corneal Disease, sponsored by Benha University. Completed at 1 site in United Arab Emirates. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-29.

Sponsored by Benha University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
63
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Corneal Disease

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Keywords

  • adenoviral
  • infiltrates
  • PTK
  • tacrolimus
03

In context

Corneal Diseases

130 studies on the registry are indexed under Corneal Diseases; 43 are open to participants now.

This study's enrollment of 63 is below the median of 102 across 46 observational studies indexed under Corneal Diseases.

Browse Corneal Diseases studies →

Lead sponsor

Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

60 patients with adenoviral SEI

Inclusion criteria

  • adenoviral SEI

Exclusion criteria

Exclusion Criteria:

  • Other corneal diseases
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
63 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DrugTacrolimus ointment

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

    Also known as: Protopic ointment

  • Procedurephototherapeutic keratectomy

    Patients underwent transepithelial PTK for subepithelial infiltrates.

06

What researchers measure

Primary outcomes

  1. changes of corneal densitometry

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

    Time frame: 6 months

07

Study locations

1 site
  • INMC
    Abu Dhabi, 46266, United Arab Emirates
08

References and documents

Publications

  • 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. PubMed 32852646 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04267991
Lead sponsor
Benha University
Responsible party
Tarek Roshdy mohamed Mahgoub ELhamaky (Lecturer, Benha University) — Principal investigator
First posted
Feb 13, 2020
Start date
Apr 1, 2018
Primary completion
Apr 1, 2020
Completion
Apr 15, 2020
Last update
May 29, 2020

Study contacts

TAREK R ELHAMAKY
principal investigator · Benha university faculty of medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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