Central Corneal ThicknessNCT06484894
The Effect of Refractive Errors on Central Corneal Thickness by Using Pentacam and IOL Master
An observational study of Central Corneal Thickness, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 41 years
- Conditions the study is for
- Central Corneal Thickness
- What is being tested?
- Pentacam and IOL master
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2024to Aug 2025
- 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 20 to 41 years
- All sexes
- Adult
Study population: 1. Inclusion criteria: Subjects included in this study aged between20 and 41 asked for refractive surgery 2. 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
Who may be able to join
- Subjects included in this study aged between20 and 41 years, asked for refractive surgery
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Conditions
- Central Corneal Thickness
- Being tested
- Pentacam and IOL master
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentacam and IOL masterDevice
Device used for measurement of central corneal thickness
| Study group | Role | What they receive |
|---|---|---|
| Hypermetrope | Effect of hypermetropia on central corneal thickness by using pentacam and IOL master Receives: Device: Pentacam and IOL master | |
| Emmetrope | Effect of emmetropia on central corneal thickness by using pentacam and IOL master Receives: Device: Pentacam and IOL master | |
| Myopia | Effect of myopia on central corneal thickness by using pentacam and IOL master Receives: Device: Pentacam and IOL master |
What is being measured
The primary outcome is the main question the study is designed to answer.
To find if there a correlation between refractive errors and the central corneal thickness
Study the effect of refractive errors on central corneal thickness
Measured: Baseline
Secondary outcomes (1)
To study if there a difference between measurement by pentacam and measurement of IOL master
Study which device is more accurate in measuring the central corneal thickness and if there is any difference between the two devices
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Central Corneal ThicknessStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haidy Nayer Adly, Assiut University
- Investigators
- Mahmoud Fathy rateb, Professor, Study director, Assiut UniversityAhmed Abd el Nasser awad, Lecturer, Study chair, Assiut UniversityMohamed Tarek Abd el menaam, Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484894
- Sponsor's protocol ID
- Central corneal thickness
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 27757993Prasad 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.
PubMed 21107245
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Refractive Errors on Central Corneal Thickness by Using Pentacam
- ClinicalTrials.gov ID
- NCT06484894
- Acronym / sponsor ID
- Central corneal thickness
- Conditions
- Central Corneal Thickness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypermetrope | – | Device: Pentacam and IOL masterEffect of hypermetropia on central corneal thickness by using pentacam and IOL master |
| Emmetrope | – | Device: Pentacam and IOL masterEffect of emmetropia on central corneal thickness by using pentacam and IOL master |
| Myopia | – | Device: Pentacam and IOL masterEffect of myopia on central corneal thickness by using pentacam and IOL master |
Who may qualify
- Ages
- 20 to 41 years
- Sex
- All
- Age groups
- Adult
- Study population
- 1. Inclusion criteria: Subjects included in this study aged between20 and 41 asked for refractive surgery 2. 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
Key inclusion criteria (1 listed)
- Subjects included in this study aged between20 and 41 years, asked for refractive surgery
Key exclusion criteria (7 listed)
- patients with corneal scarrig or opacification.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentacam and IOL masterDevice used for measurement of central corneal thickness | Device | Emmetrope, Hypermetrope, Myopia |
Primary outcome
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
1 secondary outcome
To study if there a difference between measurement by pentacam and measurement of IOL master
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 27757993Wang 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.
- Background: PubMed 21107245Prasad 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.
Related trials for Central Corneal Thickness
Active, not recruitingPhase 3
AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Corneal Endothelial Dysfunction
Not yet recruitingObservational study
Postoperative CCT in FECD vs. Non-FECD
Fuchs Endothelial Corneal Dystrophy, Cataract (Post-operative Cataract Surgery Follow-up)
Active, not recruitingObservational study
Evaluation of Central Corneal Thickness in Patients With Vernal Keratoconjunctivitis Using Topical Steroids
Vernal Keratoconjunctivitis
Recruiting
Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy
Cataract Surgery, Cataract and Fuchs Endothelial Corneal Dystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Fathy rateb, Professor study director
Assiut University
Ahmed Abd el Nasser awad, Lecturer study chair
Assiut University
Mohamed Tarek Abd el menaam, Professor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Central Corneal Thickness, run by Assiut University.
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 7 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haidy Nayer Adly, Master (01277603313, Haidynayer4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To find if there a correlation between refractive errors and the central corneal thickness (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06484894, which also lists 2 linked publications.
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 3 Jul 2024.