KeratoconusNCT05114928
Correlation Between Q-value Changes and Progression of Pediatric Keratoconus.
An observational study of Keratoconus and Collagen Diseases, run by Benha University at 1 site in Egypt.
Trial summary
Keratoconus is a progressive corneal disease characterized by asymmetric corneal thinning and structural changes in corneal collagen which leads to decrease in visual acuity due to myopic shift, irregular astigmatism or corneal scarring. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Keratoconus, Collagen Diseases, Corneal Disease
- What is being tested?
- Transepithelial Corneal Collagen Cross-linking and Scheimpflug camera
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Oct 2021to 28 Oct 2021
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: This retrospective observational study was performed at Ophthalmology department, Benha University, EGYPT using the medical records of 9 children diagnosed as bilateral progressive KC that was confirmed by Pentacam according to amsler criteria, patients had undergone bilateral TE-CXL in the period from January 2016 to August 2016 and completed annual visits till 5 years of follow-up.
Who may be able to join
- Children that were diagnosed as bilateral progressive KC (stage I-III, according to amsler classification, Kmax change >1D between 2 scanning with at least 2 months apart), and their age were less than 16 years old at time of TE-CXL, topographic parameters were Kmax 47-60D and MCT more than 400μm.
Who cannot join
- Eyes with central corneal scarring, amblyopic eyes, and other corneal pathologies that may alter Pentacam scanning.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Changes in Corneal Asphericity and Progression of Keratoconus in Children
Keratoconus is a progressive corneal disease characterized by asymmetric corneal thinning and structural changes in corneal collagen which leads to decrease in visual acuity due to myopic shift, irregular astigmatism or corneal scarring. Early detection of the disease in children aids in halting the progression and improve their quality of life. There is no consensus regarding the progression criteria of the disease, we aimed to assess the changes in corneal asphericity in children after corneal collagen crosslinking and investigate any possible correlation with progression criteria widely used.
Read the detailed description
The Keratoconus progression is defined as increasing by 1.0 diopter (D) or more in the maximum keratometry (Kmax), progressive deterioration in Minimal Corneal Thickness is also associated with KC progression, other methods have been investigated to confirm KC progression such as changes in manifest refraction, unaided visual acuity (UAVA), BCVA, posterior keratometric data and higher order aberrations (HOA) which are altered in KC and can aid to confirm disease progression. Q-value (a coefficient of corneal asphericity) reflects the shape of the cornea, its refractive power, and spherical aberration. The mean Q-value in normal cornea is -0.26 ± 0.18, the severity of KC and the Q-value are inversely related.
Mean Q-value in KC at 8mm zone is -0.84 and -1.10 for anterior and posterior corneal surfaces, respectively. Until now, no precise criteria of KC progression especially in cases had undergone previous trans-epithelial corneal collagen cross-linking (TE-CXL) to halt the progression of the disease. In the present study we aimed to analyze the correlation between the changes in Q-value and progression of the KC in children had undergone bilateral TE-CXL.
- Conditions
- Keratoconus, Collagen Diseases, Corneal Disease
- Being tested
- Transepithelial Corneal Collagen Cross-linking, Scheimpflug camera
- Keywords
- corneal asphericity, corneal collagen cross-linking, Q-value, Pediatric keratoconus, Trans-epithelial
- Medical subject headings
- Keratoconus, Collagen Diseases, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transepithelial Corneal Collagen Cross-linkingProcedure or surgery
Also called TE-CXL
Bilateral Transepithelial Corneal Collagen Cross-linking was done for all subjects using power of 9mW/cm2 at 55mm from the cornea for 10 minutes, with a total energy of 5.4j/cm2 using the (CCL VARIO, PESCHKE Trade GmbH, Huenenberg Switzerland), in the period between January 2016 to August 2016.
Scheimpflug cameraDiagnostic test
Also called Pentacam
Pentacam (OCULUS Optikgeräte GmbH, Wetzlar, Germany) was done for all subjects at baseline and annually after TE-CXL till 5 years of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Progression Group (P-group) | Eyes that showed progression of the disease after trans-epithelial corneal collagen cross-linking during the 5 years of follow-up, (number of eyes = 7 eyes). Receives: Procedure: Transepithelial Corneal Collagen Cross-linking; Diagnostic Test: Scheimpflug camera | |
| No Progression Group (NP-group) | Eyes that showed no progression of the disease after trans-epithelial corneal collagen cross-linking during the 5 years of follow-up, (number of eyes = 11 eyes). Receives: Procedure: Transepithelial Corneal Collagen Cross-linking; Diagnostic Test: Scheimpflug camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in corneal asphericity (Q-value) in all subjects.
Evaluate the changes in Q-value after Trans-epithelial corneal collagen cross-linking (TE-CXL) using pentacam.
Measured: Baseline and annually after TE-CXL till 5 years of follow-up
Secondary outcomes (2)
Correlation between Q-value changes and disease progression in both groups.
Correlation between the changes in Q-value in different corneal zones and maximum keratometry and minimal corneal thickness in both groups over 5 years of follow-up.
Measured: Baseline and annually after TE-CXL till 5 years of follow-up
The Q-value as a predictive value in keratoconus progression.
The possibility of using the Q-value parameters as a predictive values to confirm keratoconus progression in children.
Measured: Baseline and annually after TE-CXL till 5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start9 Oct 2021
- Primary completion25 Oct 2021
- Study completion28 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelshafy, Benha University
- Investigators
- Ahmed A Tabl, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114928
- Sponsor's protocol ID
- RC-10-7-01
- Status last verified
- Oct 2021
- First submitted
- 29 Oct 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Changes in Corneal Asphericity and Progression of Keratoconus in Children
- ClinicalTrials.gov ID
- NCT05114928
- Acronym / sponsor ID
- RC-10-7-01
- Conditions
- Keratoconus, Collagen Diseases, Corneal Disease
- Keywords
- corneal asphericity, corneal collagen cross-linking, Q-value, Pediatric keratoconus, Trans-epithelial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 9 Oct 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 10 Nov 2021 (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.
Keratoconus is a progressive corneal disease characterized by asymmetric corneal thinning and structural changes in corneal collagen which leads to decrease in visual acuity due to myopic shift, irregular astigmatism or corneal scarring. Early detection of the disease in children aids in halting the progression and improve their quality of life. There is no consensus regarding the progression criteria of the disease, we aimed to assess the changes in corneal asphericity in children after corneal collagen crosslinking and investigate any possible correlation with progression criteria widely used.
Detailed description
The Keratoconus progression is defined as increasing by 1.0 diopter (D) or more in the maximum keratometry (Kmax), progressive deterioration in Minimal Corneal Thickness is also associated with KC progression, other methods have been investigated to confirm KC progression such as changes in manifest refraction, unaided visual acuity (UAVA), BCVA, posterior keratometric data and higher order aberrations (HOA) which are altered in KC and can aid to confirm disease progression. Q-value (a coefficient of corneal asphericity) reflects the shape of the cornea, its refractive power, and spherical aberration. The mean Q-value in normal cornea is -0.26 ± 0.18, the severity of KC and the Q-value are inversely related.
Mean Q-value in KC at 8mm zone is -0.84 and -1.10 for anterior and posterior corneal surfaces, respectively. Until now, no precise criteria of KC progression especially in cases had undergone previous trans-epithelial corneal collagen cross-linking (TE-CXL) to halt the progression of the disease. In the present study we aimed to analyze the correlation between the changes in Q-value and progression of the KC in children had undergone bilateral TE-CXL.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progression Group (P-group) | – | Procedure: Transepithelial Corneal Collagen Cross-linking, Diagnostic Test: Scheimpflug cameraEyes that showed progression of the disease after trans-epithelial corneal collagen cross-linking during the 5 years of follow-up, (number of eyes = 7 eyes). |
| No Progression Group (NP-group) | – | Procedure: Transepithelial Corneal Collagen Cross-linking, Diagnostic Test: Scheimpflug cameraEyes that showed no progression of the disease after trans-epithelial corneal collagen cross-linking during the 5 years of follow-up, (number of eyes = 11 eyes). |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This retrospective observational study was performed at Ophthalmology department, Benha University, EGYPT using the medical records of 9 children diagnosed as bilateral progressive KC that was confirmed by Pentacam according to amsler criteria, patients had undergone bilateral TE-CXL in the period from January 2016 to August 2016 and completed annual visits till 5 years of follow-up.
Key inclusion criteria (1 listed)
- Children that were diagnosed as bilateral progressive KC (stage I-III, according to amsler classification, Kmax change >1D between 2 scanning with at least 2 months apart), and their age were less than 16 years old at time of TE-CXL, topographic parameters were Kmax 47-60D and MCT more than 400μm.
Key exclusion criteria (1 listed)
- Eyes with central corneal scarring, amblyopic eyes, and other corneal pathologies that may alter Pentacam scanning.
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 |
|---|---|---|
| Transepithelial Corneal Collagen Cross-linkingAlso: TE-CXLBilateral Transepithelial Corneal Collagen Cross-linking was done for all subjects using power of 9mW/cm2 at 55mm from the cornea for 10 minutes, with a total energy of 5.4j/cm2 using the (CCL VARIO, PESCHKE Trade GmbH, Huenenberg Switzerland), in the period between January 2016 to August 2016. | Procedure or surgery | No Progression Group (NP-group), Progression Group (P-group) |
| Scheimpflug cameraAlso: PentacamPentacam (OCULUS Optikgeräte GmbH, Wetzlar, Germany) was done for all subjects at baseline and annually after TE-CXL till 5 years of follow-up. | Diagnostic test | No Progression Group (NP-group), Progression Group (P-group) |
Primary outcome
Changes in corneal asphericity (Q-value) in all subjects.
Time frame: Baseline and annually after TE-CXL till 5 years of follow-up
Evaluate the changes in Q-value after Trans-epithelial corneal collagen cross-linking (TE-CXL) using pentacam.
2 secondary outcomes
Correlation between Q-value changes and disease progression in both groups.
Time frame: Baseline and annually after TE-CXL till 5 years of follow-up
The Q-value as a predictive value in keratoconus progression.
Time frame: Baseline and annually after TE-CXL till 5 years of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Keratoconus
RecruitingObservational study
UNITY DX Cornea Study
Tomography
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
Keratoconus, Presbyopia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
Keratoconus, Keratoconus, Unstable
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.
Ahmed A Tabl, MD principal investigator
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus and Collagen Diseases, run by Benha 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 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 10 Nov 2021. 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?
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?
Changes in corneal asphericity (Q-value) in all subjects. (time frame: Baseline and annually after TE-CXL till 5 years of follow-up). 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 10 Nov 2021.