CorneaNCT06963099
INTACS for Non Ectatic With High Cylinder
A study testing INTACS implantation in people with Cornea, run by Elshimaa A.Mateen at 1 site in Egypt.
Trial summary
Intra-corneal rings implantation for correcting high cylinder errors in non ectatic corneas Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cornea
- What is being tested?
- INTACS implantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Non ectatic corneas with high cylinder error
Who cannot join
- Corneal ectasia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Elshimaa A.Mateen
Sohag
Elshimaa A.Mateen, Doctor, 0201282223427, elshimaa.moussa@yahoo.com
About this study
Official title: Use of Intra-corneal Ring Segments in Management of Non-ectatic Corneas With High Cylinder
Intra-corneal rings implantation for correcting high cylinder errors in non ectatic corneas
- Conditions
- Cornea
- Being tested
- INTACS implantation
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTACS implantationOther
intra corneal segments implantation
| Study group | Role | What they receive |
|---|---|---|
| High cylinder group | Other | Not described Receives: Other: INTACS implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of (1)visual acuity in log mar (2) keratometry readings in diopter 1) refraction. 2)High order aberrations
Using: (1) auto-refractometer (2) pentacam to assess keratometry changes.
Measured: six months
changes of corneal parameters (K1.K2,K max) in diopter
Comparing pentacam readings pre and post operative.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Dec 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CorneaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elshimaa A.Mateen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elshimaa A.Mateen, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963099
- Sponsor's protocol ID
- Soh-Med-25-4-2PD
- Status last verified
- May 2025
- First submitted
- 21 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mounir A, Mossa EAM, Mahmoud A. Outcomes of keraring implantation for high regular astigmatism in non-ectatic corneas: A prospective pilot case series. Sci Rep. 2026 Jun 17;16(1):18859. doi: 10.1038/s41598-026-57128-7.
PubMed 42310410
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Intra-corneal Ring Segments in Management of Non-ectatic Corneas With High Cylinder
- ClinicalTrials.gov ID
- NCT06963099
- Acronym / sponsor ID
- Soh-Med-25-4-2PD
- Conditions
- Cornea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Elshimaa A.MateenUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 8 May 2025 (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.
Intra-corneal rings implantation for correcting high cylinder errors in non ectatic corneas
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High cylinder group | Other | Other: INTACS implantation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Non ectatic corneas with high cylinder error
Key exclusion criteria (1 listed)
- Corneal ectasia
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 |
|---|---|---|
| INTACS implantationintra corneal segments implantation | Other | High cylinder group |
Primary outcome
Change of (1)visual acuity in log mar (2) keratometry readings in diopter 1) refraction. 2)High order aberrations
Time frame: six months
Using: (1) auto-refractometer (2) pentacam to assess keratometry changes.
changes of corneal parameters (K1.K2,K max) in diopter
Time frame: six months
Comparing pentacam readings pre and post operative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Derived from this study: PubMed 42310410Mounir A, Mossa EAM, Mahmoud A. Outcomes of keraring implantation for high regular astigmatism in non-ectatic corneas: A prospective pilot case series. Sci Rep. 2026 Jun 17;16(1):18859. doi: 10.1038/s41598-026-57128-7.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTACS implantation in people with Cornea, run by Elshimaa A.Mateen 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: looking for participants now, as of the sponsor's last update on 14 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elshimaa A.Mateen, Doctor (0021282223427 ext. Sohag, elshimaa.moussa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of (1)visual acuity in log mar (2) keratometry readings in diopter 1) refraction. 2)High order aberrations (time frame: six months). The study lists 2 primary outcomes in all. 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 NCT06963099, which also lists 1 linked publication.
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 14 May 2025.