Eye ChangeNCT05626075
Correlation Between Corneal Topographic Patterns and Refractive Status Of The Eye in Sohag City,Egypt
A study testing Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions. in people with Eye Change, run by Sohag University at 1 site in Egypt.
Trial summary
To evaluate corneal topographic pattern \& its correlation with refractive status of the eye . Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Change
- What is being tested?
- Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Sep 2022to Mar 2023
- Phase
- Interventional
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients aging more than 15 years old
- All patients are with visual acuity (uncorrected, with habitual correction, and best spectacle correction).
- There is no restrictions on the range and regularity of keratometry.
Who cannot join
- Patients with a history of any trauma to the eye.
- Patients with recent contact lens wear.
- history of ocular surgery .
- Patients with distance corrected visual acuity or abnormal retinoscopy examination (e.g., scissoring reflex).
- 5. If there was any error in reading the topographic map. 6. Patients with anemotropic refraction.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Facultyof medicine
Sohag, 82425
Mohamed Iqbal, Md.PhD, 00201068559840, dr_m_iqbal@yahoo.com
About this study
To evaluate corneal topographic pattern \& its correlation with refractive status of the eye .
Read the detailed description
This study will be established in The Future Center for refractive surgery, Sohag, Egypt.
This study will include 100 eyes of patients aged over 15 years. All patients were subjected to topography imaging.
Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions.
The scheimpflug principle describes the optical imaging condition when the plane of an object is not parallel to the film of the camera and has to cut each other in one line or one point of intersection with the advantage to achieve wide depth of focus.
Scheimpflug imaging attains a wide and high depth-of-focus , providing sharp images that include information from an anterior corneal surface through to the posterior crystalline capsule; this depends mainly on media transparency and pupil size .
- Conditions
- Eye Change
- Being tested
- Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions.
- Keywords
- Topographic, visual acuity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions.Diagnostic test
Also called The scheimpflug principle describes the optical imaging condition
Scheimpflug imaging attains a wide and high depth-of-focus , providing sharp images that include information from an anterior corneal surface through to the posterior crystalline capsule
| Study group | Role | What they receive |
|---|---|---|
| group Low Myopia | Experimental | 1. Patients with low myopia aging more than 15 years old
2. All patients are with visual acuity (uncorrected, with habitual correction, and best spectacle correction).
3. There is no restrictions on the range and regularity of keratometry Receives: Diagnostic Test: Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions. |
| group high myopia | Experimental | 1. Patients with high myopia aging more than 15 years old
2. All patients are with visual acuity (uncorrected, with habitual correction, and best spectacle correction).
3. There is no restrictions on the range and regularity of keratometry Receives: Diagnostic Test: Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions. |
| group Hypermetropia | Experimental | 1. Patients with hypermetropia aging more than 15 years old
2. All patients are with visual acuity (uncorrected, with habitual correction, and best spectacle correction).
3. There is no restrictions on the range and regularity of keratometry Receives: Diagnostic Test: Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions. |
| group mixed astigmatism | Experimental | 1. Patients with mixed astigmatism aging more than 15 years old
2. All patients are with visual acuity (uncorrected, with habitual correction, and best spectacle correction).
3. There is no restrictions on the range and regularity of keratometry Receives: Diagnostic Test: Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness
Topographic values using Oculus Pentacam®
Measured: 3 months after begin of study
degree of astigmatism in D
Topographic values using Oculus Pentacam®
Measured: 3 months after begin of study
maximum keratometry
Topographic values using Oculus Pentacam®
Measured: 3 months after begin of study
front and back elevation of the apex (um).
Topographic values using Oculus Pentacam®
Measured: 3 months after begin of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start22 Sep 2022
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye ChangeStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdallah Abdelaal, Sohag University
- Investigators
- Mohamed Iqbal, MD.PhD, Study chair, Sohag Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626075
- Sponsor's protocol ID
- Soh-Med-22-07-2014
- Status last verified
- Nov 2022
- First submitted
- 12 Oct 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Corneal Topographic Patterns and Refractive Status Of The Eye in Sohag City,Egypt
- ClinicalTrials.gov ID
- NCT05626075
- Acronym / sponsor ID
- Soh-Med-22-07-2014
- Conditions
- Eye Change
- Keywords
- Topographic, visual acuity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 23 Nov 2022 (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 corneal topographic pattern \& its correlation with refractive status of the eye .
Detailed description
This study will be established in The Future Center for refractive surgery, Sohag, Egypt.
This study will include 100 eyes of patients aged over 15 years. All patients were subjected to topography imaging.
Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions.
The scheimpflug principle describes the optical imaging condition when the plane of an object is not parallel to the film of the camera and has to cut each other in one line or one point of intersection with the advantage to achieve wide depth of focus.
Scheimpflug imaging attains a wide and high depth-of-focus , providing sharp images that include information from an anterior corneal surface through to the posterior crystalline capsule; this depends mainly on media transparency and pupil size .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group Low Myopia | Experimental | Diagnostic Test: Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions.1. Patients with low myopia aging more than 15 years old 2. All patients are with visual acuity (uncorrected, with habitual correction, and best spectacle correction). 3. There is no restrictions on the range and regularity of keratometry |
| group high myopia | Experimental | Diagnostic Test: Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions.1. Patients with high myopia aging more than 15 years old 2. All patients are with visual acuity (uncorrected, with habitual correction, and best spectacle correction). 3. There is no restrictions on the range and regularity of keratometry |
| group Hypermetropia | Experimental | Diagnostic Test: Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions.1. Patients with hypermetropia aging more than 15 years old 2. All patients are with visual acuity (uncorrected, with habitual correction, and best spectacle correction). 3. There is no restrictions on the range and regularity of keratometry |
| group mixed astigmatism | Experimental | Diagnostic Test: Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions.1. Patients with mixed astigmatism aging more than 15 years old 2. All patients are with visual acuity (uncorrected, with habitual correction, and best spectacle correction). 3. There is no restrictions on the range and regularity of keratometry |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aging more than 15 years old
- All patients are with visual acuity (uncorrected, with habitual correction, and best spectacle correction).
- There is no restrictions on the range and regularity of keratometry.
Key exclusion criteria (5 listed)
- Patients with a history of any trauma to the eye.
- Patients with recent contact lens wear.
- history of ocular surgery .
- Patients with distance corrected visual acuity or abnormal retinoscopy examination (e.g., scissoring reflex).
- 5. If there was any error in reading the topographic map. 6. Patients with anemotropic refraction.
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 |
|---|---|---|
| Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions.Also: The scheimpflug principle describes the optical imaging conditionScheimpflug imaging attains a wide and high depth-of-focus , providing sharp images that include information from an anterior corneal surface through to the posterior crystalline capsule | Diagnostic test | group Hypermetropia, group Low Myopia, group high myopia, group mixed astigmatism |
Primary outcome
Thickness
Time frame: 3 months after begin of study
Topographic values using Oculus Pentacam®
degree of astigmatism in D
Time frame: 3 months after begin of study
Topographic values using Oculus Pentacam®
maximum keratometry
Time frame: 3 months after begin of study
Topographic values using Oculus Pentacam®
front and back elevation of the apex (um).
Time frame: 3 months after begin of study
Topographic values using Oculus Pentacam®
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Mohamed Iqbal, MD.PhD study chair
Sohag Faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions. in people with Eye Change, run by Sohag University at 1 site in Egypt.
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 3 inclusion and 5 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 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mohamed Iqbal, MD.PhD (00201068559840, dr_m_iqbal@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness (time frame: 3 months after begin of study). The study lists 4 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 23 Nov 2022.