KeratoconusNCT04562064
Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus.
An observational study of Keratoconus, run by Assiut University at 1 site in Egypt.
Trial summary
keratoconus is a progressive corneal ectatic disease characterized by paraxial stromal thinning and weakening, resulting in irregular astigmatism, corneal protrusion, and distortion of the anterior corneal surface. It is usually bilateral, although asymmetrical in most cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- corneal tomography scans
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to Nov 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with keratoconus implanted with the Myoring 360 degree, KeraRing 355 degree, KeraRing one segment, KeraRing two segments ICRS .corneal tomography scans of the two corneal surfaces were obtained preoperatively and postoperatively with a rotating Scheimpflug imaging system .pentacam data that will be included
Who may be able to join
- Keratoconus grade I, II and III according to the mean K Amsler-Krumeich classification.
- Contact lens intolerance.
- Thinnest location is more than 400 um.
- Maximum keratometry (Kmax) between 48 and 64 D.
- Clear cornea with no Vogt's striae.
Who cannot join
- Previous corneal surgery.
- Grade IV with corneal scarring.
- Concurrent corneal disease in addition to KC.
- Autoimmune or systemic connective tissue diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut Faculty of Medicine
Asyut
Ahmed Abbas, MD, 00201003385183, bmr90@hotmail.com
About this study
keratoconus is a progressive corneal ectatic disease characterized by paraxial stromal thinning and weakening, resulting in irregular astigmatism, corneal protrusion, and distortion of the anterior corneal surface. It is usually bilateral, although asymmetrical in most cases.
Intrastromal corneal rings are polymethylmethacrylate devices successfully used for the management of keratoconus, pellucid marginal degeneration, post-LASIK ectasia and myopia. Intrastromal corneal rings implantation is safe and reversible procedure that does not affect the central corneal area, and hence, avoids interference with visual axis. The goal of intrastromal corneal rings implantation is to improve visual acuity by regulariztion of the anterior corneal surface.
- Conditions
- Keratoconus
- Being tested
- corneal tomography scans
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corneal tomography scansDevice
corneal tomography scans of the two corneal surfaces were obtained preoperatively and postoperatively with a rotating Scheimpflug imaging system
| Study group | Role | What they receive |
|---|---|---|
| keratoconus group | patients with keratoconus implanted with the Myoring 360 degree, KeraRing 355 degree, KeraRing one segment, KeraRing two segments ICRS .corneal tomography scans of the two corneal surfaces were obtained preoperatively and postoperatively with a rotating Scheimpflug imaging system .pentacam data that will be included Receives: Device: corneal tomography scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of changes of anterior corneal surface preoperatively compared to those values postoperativaly
The changes of anterior corneal surface including flat (K1) and steep (K2) keratometry values, corneal astigmatism (Astig) preoperatively compared to those values postoperativaly
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Dec 2020
- Primary completionSep 2022 (estimated)
- Study completionNov 2022 (estimated)
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.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562064
- Sponsor's protocol ID
- PICR
- Status last verified
- Aug 2022
- First submitted
- 18 Sep 2020
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- 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 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus.
- ClinicalTrials.gov ID
- NCT04562064
- Acronym / sponsor ID
- PICR
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 24 Sep 2020 (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 ectatic disease characterized by paraxial stromal thinning and weakening, resulting in irregular astigmatism, corneal protrusion, and distortion of the anterior corneal surface. It is usually bilateral, although asymmetrical in most cases.
Intrastromal corneal rings are polymethylmethacrylate devices successfully used for the management of keratoconus, pellucid marginal degeneration, post-LASIK ectasia and myopia. Intrastromal corneal rings implantation is safe and reversible procedure that does not affect the central corneal area, and hence, avoids interference with visual axis. The goal of intrastromal corneal rings implantation is to improve visual acuity by regulariztion of the anterior corneal surface.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| keratoconus group | – | Device: corneal tomography scanspatients with keratoconus implanted with the Myoring 360 degree, KeraRing 355 degree, KeraRing one segment, KeraRing two segments ICRS .corneal tomography scans of the two corneal surfaces were obtained preoperatively and postoperatively with a rotating Scheimpflug imaging system .pentacam data that will be included |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with keratoconus implanted with the Myoring 360 degree, KeraRing 355 degree, KeraRing one segment, KeraRing two segments ICRS .corneal tomography scans of the two corneal surfaces were obtained preoperatively and postoperatively with a rotating Scheimpflug imaging system .pentacam data that will be included
Key inclusion criteria (5 listed)
- Keratoconus grade I, II and III according to the mean K Amsler-Krumeich classification.
- Contact lens intolerance.
- Thinnest location is more than 400 um.
- Maximum keratometry (Kmax) between 48 and 64 D.
- Clear cornea with no Vogt's striae.
Key exclusion criteria (4 listed)
- Previous corneal surgery.
- Grade IV with corneal scarring.
- Concurrent corneal disease in addition to KC.
- Autoimmune or systemic connective tissue diseases.
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 |
|---|---|---|
| corneal tomography scanscorneal tomography scans of the two corneal surfaces were obtained preoperatively and postoperatively with a rotating Scheimpflug imaging system | Device | keratoconus group |
Primary outcome
The percentage of changes of anterior corneal surface preoperatively compared to those values postoperativaly
Time frame: 1 month
The changes of anterior corneal surface including flat (K1) and steep (K2) keratometry values, corneal astigmatism (Astig) preoperatively compared to those values postoperativaly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 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.
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, run by Assiut 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 5 inclusion and 4 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 25 Aug 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 Magdi M Mostafa, MD (01093122344, magdimohammad2013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of changes of anterior corneal surface preoperatively compared to those values postoperativaly (time frame: 1 month). 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 25 Aug 2022.