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KeratoconusNCT03288116

Objective and Subjective Diagnostic Parameters in the Fellow Eye of Unilateral Keratoconus

An observational study of Keratoconus, run by Dar Al Shifa Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

patients with keratoconus in one eye and forme fruste keratoconus in the fellow eye compared to normal subjects .the patients were examined by schemipflug imaging system (Pentacam) Read more about this study

Who is it for?
Ages 14 to 44 yearsHealthy volunteers can take part
Conditions the study is for
Keratoconus
What is being tested?
Scheimplug imaging and contrast and sensitivity test
How many people
48 participants
Where
No sites listed yet
Study dates
2 Jan 2014to 5 Feb 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 44 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: unilateral keratoconus

Who may be able to join

  • patients with clinically evident keratoconus in one eye and apparently normal in the fellow eye

Who cannot join

  • previous ocular surgery or truama,significant corneal scarring or associatedocular pathology

About this study

Official title: Literature in Mansoura Ophthalmic Center ,Mansoura University

patients with keratoconus in one eye and forme fruste keratoconus in the fellow eye compared to normal subjects .the patients were examined by schemipflug imaging system (Pentacam)

Read the detailed description

This cross-sectional study was carried out on patients presenting keratoconus in one eye and forme fruste keratoconus in the fellow eye; the patients attended the outpatient clinic of Mansoura ophthalmic center between January 2014 and February 2015. This study was approved by the institutional research board of the Mansoura faculty of medicine and was performed in accordance with the ethical standards of the Declaration of Helsinki. All patients included in the study provided informed consent.

Ocular examinations were performed on all eyes included in the study. Clinical Keratoconus was diagnosed if all the following criteria were found:1)asymmetric bow tie with skewed radial axis (SRAX), inferior or central steepening on the topography map, 2)mean keratometry (K)>47diopters or an inferior-superior (I-S) value >1.4diopters according to the Rabinowitz and McDonnell criteria[8],and 3)at least one clinical symptom(i.e., stromal thinning, conical protrusion of corneal apex,Fleischer ring, Vogt striae or anterior stromal scar). Forme fruste keratoconus was diagnosed if all the following criteria were found: 1) normal topography, 2) mean K<47D and I-S ≤1.4,3) normal slit lamp, and 4)keratoconus in the fellow eye.

The eyes with an evident keratoconus diagnosis were included in (Group A)and the fellow eyes were included in (Group B).Control cases(Group C) were selected from the normal database of candidates for refractive surgery with the following:1)normal topography, 2)negative rotating Scheimpflug device indices and negative topographic keratoconus classification, 3)normal slit lamp examination, and 4)no history of eye disease(only one eye of each normal candidate was included in the study depending on a computer-based randomizing program).

The exclusion criteria included previous ocular surgery or trauma, significant corneal scarring or associated ocular pathology.

All eyes were examined by rotating Scheimpflug corneal tomography (Pentacam, Oculus Optikgerate GmbH).No patients in the study wore contact lenses. During the Scheimpflug corneal tomography examination, the patient was properly positioned on the chin rest and forehead strap. The patient was asked to blink several times then open both eyes and stare at a fixed target. After obtaining proper alignment, the automatic release mode started the scan; a total of25 single Scheimpflug images were captured within 2 sec for each eye. Three consecutive scans were taken of each eye by the same examiner. The average of the results of three acceptable measurements was included in the study. Each eye was required to have a corneal map with at least 9 mm of corneal coverage and no extrapolated data.

The Pentacam maps were analyzed. The following anterior and posterior corneal surface parameters were evaluated by the Scheimpflug system: corneal dioptric power at the flattest meridian in the 3 mm-central zone(K1),corneal dioptric power in the steepest meridian in the 3mm-central zone (K2)and mean corneal power in the 3mm-zone (mean K).

The pachymetric map was analyzed, including the central corneal thickness (CCT) at the apex of the geometric center and corneal thickness at the thinnest point (CTmin).The average progression index (PPI avg) was calculated as the progression value at the different rings referenced to the mean curve. The minimum (PPI min) and maximum (PPI max) progression indices were recorded. The Ambrósior elational thickness (ART)was calculated as follows: ARTavg=CTmin/PPIavg,ARTmin = CTmin/PPImin, ARTmax =CTmin/PPImax[9].

The posterior corneal elevation maps were evaluated; a reference best fit sphere was calculated at a fixed optical zone of 8 mm, and the posterior corneal elevation values relative to this reference were recorded. The back difference elevation and multimetric D index values were extrapolated from the difference map of the Belin/Ambrósio-enhanced ectasia display of the Pentacam system.

Contrast and Glare sensitivity test:

The contract and glare tests were carried out with a Mesotest II (Oculus Optikgeräte GmbH, Wetzlar, Germany), which consists of Landolt rings of different contrast levels presented in front of a low-brightness background. There are 4 contrast levels, 1:23, 1:5, 1:2.7, and 1:2, which represent the ratio between the light intensity of the optotypes and the background. There were 8 tests, 4 without glare and 4 with glare. Test 1, with a contrast level of 1:23, is the most easily recognized. For statistical purposes, each level of the contrast or glare test was given a score ranging from 20% at the 1:23 level to 100% at the 1:2 level.

Conditions
Keratoconus
Being tested
Scheimplug imaging and contrast and sensitivity test
Medical subject headings
Keratoconus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Scheimplug imaging and contrast and sensitivity testDiagnostic test

    examination of the patients using the schemiplug imaging with evaluation of keratometric parametres ,pachymetric parametres ,elevation parameters.

Study groups in NCT03288116
Study groupRoleWhat they receive
patientScheimplug imaging and contrast and sensitivity test
Receives: Diagnostic Test: Scheimplug imaging and contrast and sensitivity test
early diseaseScheimplug imaging and contrast and sensitivity test
Receives: Diagnostic Test: Scheimplug imaging and contrast and sensitivity test
normalScheimplug imaging and contrast and sensitivity test
Receives: Diagnostic Test: Scheimplug imaging and contrast and sensitivity test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. keratometric power of the corneal surface

    in diopter

    Measured: 1 year

  2. corneal thickness(pachymetry)

    in micrometer

    Measured: 1 year

  3. corneal elevations

    in micrometer

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2017
  2. Study start2 Jan 2014
  3. Primary completion5 Feb 2015
  4. Study completion5 Feb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03288116
Sponsor's protocol ID
2352
Status last verified
Sep 2017
First submitted
30 Aug 2017
Last updated
19 Sep 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Keratoconus, run by Dar Al Shifa Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

keratometric power of the corneal surface (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.

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