Cornea EctasiaNCT06498570
Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus
A study testing Intracorneal rings in people with Cornea Ectasia, run by Sohag University at 1 site in Egypt.
Trial summary
Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Cornea Ectasia
- What is being tested?
- Intracorneal rings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 10 Jan 2024
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- stable keratoconus.
- corneal cross-linking performed at least 6 months.
- contact lens intolerance
- minimum corneal thickness of 350 μm at the thinnest point (TP)
- mean keratometry (K mean) value less than 59 D
Who cannot join
- any other associated ocular or systemic pathology could affect the vision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus; A Retrospective Non-Randomized Study
Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus
Read the detailed description
a retrospective non- randomized controlled clinical study. The study included twenty-three grade 3 keratoconic eyes of twenty-three patients, the keratoconus staging was based on Amsler-Krumeich classification The ICRS surgery was performed with the patient under topical anesthesia. A tunnel channel was created by femtosecond laser using a 60-kHz infrared neodymium glass femtosecond laser at a wavelength of 1053 nm (Abbott Laboratories Inc., Abbott Park, Illinois, USA). Two symmetrical kerarings (Mediphacos Inc., Belo Horizonte, Brazil), were implanted in all cases with 160° arc and 0.25, 0.30 mm according to corneal thickness in implantation site. After surgery, the patients had a full ocular evaluation on days 1, 7, and 14, and again after a month. For a period of 1-year, corneal topography readings were taken quarterly.
- Conditions
- Cornea Ectasia
- Being tested
- Intracorneal rings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracorneal ringsDevice
Also called INTACS
The (ICRS), intracorneal rings segments implantation surgery
| Study group | Role | What they receive |
|---|---|---|
| grade 3 keratoconic eyes Grade 3 eyes with stable keratoconus | Other | grade 3 keratoconic eyes Grade 3 eyes with stable keratoconus Receives: Device: Intracorneal rings |
What is being measured
The primary outcome is the main question the study is designed to answer.
K1 and K2 post-operative by Pentacam
Flat and Steep K in Diopter post ring implantation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Jan 2022
- Primary completion20 Dec 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cornea EctasiaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elshimaa A.Mateen, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498570
- Sponsor's protocol ID
- Soh-MED-24-05--03PD
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus; A Retrospective Non-Randomized Study
- ClinicalTrials.gov ID
- NCT06498570
- Acronym / sponsor ID
- Soh-MED-24-05--03PD
- Conditions
- Cornea Ectasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 12 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.
Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus
Detailed description
a retrospective non- randomized controlled clinical study. The study included twenty-three grade 3 keratoconic eyes of twenty-three patients, the keratoconus staging was based on Amsler-Krumeich classification The ICRS surgery was performed with the patient under topical anesthesia. A tunnel channel was created by femtosecond laser using a 60-kHz infrared neodymium glass femtosecond laser at a wavelength of 1053 nm (Abbott Laboratories Inc., Abbott Park, Illinois, USA). Two symmetrical kerarings (Mediphacos Inc., Belo Horizonte, Brazil), were implanted in all cases with 160° arc and 0.25, 0.30 mm according to corneal thickness in implantation site. After surgery, the patients had a full ocular evaluation on days 1, 7, and 14, and again after a month. For a period of 1-year, corneal topography readings were taken quarterly.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| grade 3 keratoconic eyes Grade 3 eyes with stable keratoconus | Other | Device: Intracorneal ringsgrade 3 keratoconic eyes Grade 3 eyes with stable keratoconus |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- stable keratoconus.
- corneal cross-linking performed at least 6 months.
- contact lens intolerance
- minimum corneal thickness of 350 μm at the thinnest point (TP)
- mean keratometry (K mean) value less than 59 D
Key exclusion criteria (1 listed)
- any other associated ocular or systemic pathology could affect the vision.
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 |
|---|---|---|
| Intracorneal ringsAlso: INTACSThe (ICRS), intracorneal rings segments implantation surgery | Device | grade 3 keratoconic eyes Grade 3 eyes with stable keratoconus |
Primary outcome
K1 and K2 post-operative by Pentacam
Time frame: one year
Flat and Steep K in Diopter post ring implantation
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 12 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Cornea Ectasia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia
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RecruitingObservational study
Corneal Elastography and Patient Specific Modeling
Cornea; Ectasia, Refractive Errors
Not yet recruitingPhase 4
Outcomes of CTAK Surgery
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RecruitingPhase 3
Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
Keratoconus, Ectasia of Cornea
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracorneal rings in people with Cornea Ectasia, 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 5 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 12 Jul 2024. 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?
K1 and K2 post-operative by Pentacam (time frame: one year). 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 12 Jul 2024.