- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06484894
The Effect of Refractive Errors on Central Corneal Thickness by Using Pentacam and IOL Master
June 26, 2024 updated by: Haidy Nayer Adly, Assiut University
The Effect of Refractive Errors on Central Corneal Thickness by Using Pentacam
To evaluate the impact of refractive errors on the central corneal thickness obtained by Pentacam and intraocular lenses (IOL) master in eyes with different refractive errors.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Central corneal thickness (CCT) is a key indicator of corneal health status and helps to assess corneal diseases.
The normal corneal thickness is about 540 μm and mainly consists of the stroma, which is estimated at 450 μm in the center.
The stroma provides vital structural integrity and plays a key role in helping maintain transparency.
It has been reported, however, that CCT follows a diurnal pattern being 10 μm thicker in the morning due to reduced evaporation of water from underneath the closed eyelids
Study Type
Observational
Enrollment (Estimated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Haidy Nayer Adly, Master
- Phone Number: 01277603313
- Email: Haidynayer4@gmail.com
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
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Inclusion criteria:
Subjects included in this study aged between20 and 41 asked for refractive surgery
Exclusion criteria:-
- Severe corneal scarrig or opacification., dystrophy
- Patients with history of recent contact lens Ocular trauma.
- Uveitis patients Patients with keratoconus.
- Previous ocular or refractive surgey
Description
Inclusion Criteria:
- Subjects included in this study aged between20 and 41 years, asked for refractive surgery
Exclusion Criteria:
patients with corneal scarrig or opacification.
- Patients with corneal dystrophies.
- Patients with keratoconus.
- Previous ocular or refractive surgery.
- Ocular trauma.
- Uveitis patients.
- Patients with history of recent contact lens wear.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hypermetrope
Effect of hypermetropia on central corneal thickness by using pentacam and IOL master
|
Device used for measurement of central corneal thickness
|
|
Emmetrope
Effect of emmetropia on central corneal thickness by using pentacam and IOL master
|
Device used for measurement of central corneal thickness
|
|
Myopia
Effect of myopia on central corneal thickness by using pentacam and IOL master
|
Device used for measurement of central corneal thickness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To find if there a correlation between refractive errors and the central corneal thickness
Time Frame: Baseline
|
Study the effect of refractive errors on central corneal thickness
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To study if there a difference between measurement by pentacam and measurement of IOL master
Time Frame: Baseline
|
Study which device is more accurate in measuring the central corneal thickness and if there is any difference between the two devices
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mahmoud Fathy rateb, Professor, Assiut University
- Study Chair: Ahmed Abd el Nasser awad, Lecturer, Assiut University
- Principal Investigator: Mohamed Tarek Abd el menaam, Professor, Assiut University
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
- Wang Q, Liu W, Wu Y, Ma Y, Zhao G. Central corneal thickness and its relationship to ocular parameters in young adult myopic eyes. Clin Exp Optom. 2017 May;100(3):250-254. doi: 10.1111/cxo.12485. Epub 2016 Oct 18.
- Prasad A, Fry K, Hersh PS. Relationship of age and refraction to central corneal thickness. Cornea. 2011 May;30(5):553-5. doi: 10.1097/ICO.0b013e3181fb880c.
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 (Estimated)
July 15, 2024
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
June 26, 2024
First Submitted That Met QC Criteria
June 26, 2024
First Posted (Actual)
July 3, 2024
Study Record Updates
Last Update Posted (Actual)
July 3, 2024
Last Update Submitted That Met QC Criteria
June 26, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Central corneal thickness
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
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