Intracorneal RingSTAKNCT05596838
Long-term Result of Placing Intracorneal Rings in Keratoconus Using Laser
An observational study of Intracorneal Ring and Keratoconus, run by Elsan at 1 site in France.
Trial summary
Intracorneal rings are indicated in patients whose central cornea does not present opacity and whose visual acuity is not satisfied despite correction with lenses or linked to an intolerance to lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracorneal Ring, Keratoconus, Laser
- What is being tested?
- Intracorneal rings placement
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2023to Jan 2026
- 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: Patient operated at Somain institue with the placement f intra-corneal rings using laser
Who may be able to join
- Patient having received the information notice/non-objection
- Adult man or woman (over 18)
- Failure of a lens fitting adaptation
- Patient with a diagnosis of keratoconus
- Patient operated at Somain institute with the placement of intra-corneal rings
Who cannot join
- Minor
- Post-lasik ectasia
- Iatrogenic Keratoconus
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
About this study
Intracorneal rings are indicated in patients whose central cornea does not present opacity and whose visual acuity is not satisfied despite correction with lenses or linked to an intolerance to lenses.
Surgeries such as crosslinking and intracorneal rings placement are alternatives to corneal transplantation with the expected effects: stabilization of the disease for corneal collagen crosslinking and visual rehabilitation by the placement of intracorneal rings.
The main objective of this study is to evaluate visual benefit1 year after placement of intracorneal rings using laser in keratoconus
- Conditions
- Intracorneal Ring, Keratoconus, Laser
- Being tested
- Intracorneal rings placement
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracorneal rings placementProcedure or surgery
Intracorneal rings placement in keratoconus using laser
| Study group | Role | What they receive |
|---|---|---|
| Patient operated at Somain institute with the placement of intracorneal rings | patient operated in the last 10 years on one or both eyes Receives: Procedure: Intracorneal rings placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity (BCVA) evolution. Visual acuity will be expressed in logMAR.
Evolution of the best corrected visual acuity (BCVA) 1 year after the installation of intra-corneal rings compared to the preoperative value. Visual acuity will be expressed in logMAR.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start20 Jan 2023
- Primary completion1 Mar 2024
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracorneal RingStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596838
- Sponsor's protocol ID
- STAK
- Acronym
- STAK
- Status last verified
- Mar 2024
- First submitted
- 24 Oct 2022
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Result of Placing Intracorneal Rings in Keratoconus Using Laser
- ClinicalTrials.gov ID
- NCT05596838
- Acronym / sponsor ID
- STAK / STAK
- Conditions
- Intracorneal Ring, Keratoconus, Laser
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- Jan 2026 (estimated)
- First posted
- 27 Oct 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.
Intracorneal rings are indicated in patients whose central cornea does not present opacity and whose visual acuity is not satisfied despite correction with lenses or linked to an intolerance to lenses.
Surgeries such as crosslinking and intracorneal rings placement are alternatives to corneal transplantation with the expected effects: stabilization of the disease for corneal collagen crosslinking and visual rehabilitation by the placement of intracorneal rings.
The main objective of this study is to evaluate visual benefit1 year after placement of intracorneal rings using laser in keratoconus
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient operated at Somain institute with the placement of intracorneal rings | – | Procedure: Intracorneal rings placementpatient operated in the last 10 years on one or both eyes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient operated at Somain institue with the placement f intra-corneal rings using laser
Key inclusion criteria (5 listed)
- Patient having received the information notice/non-objection
- Adult man or woman (over 18)
- Failure of a lens fitting adaptation
- Patient with a diagnosis of keratoconus
- Patient operated at Somain institute with the placement of intra-corneal rings
Key exclusion criteria (4 listed)
- Minor
- Post-lasik ectasia
- Iatrogenic Keratoconus
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
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 rings placementIntracorneal rings placement in keratoconus using laser | Procedure or surgery | Patient operated at Somain institute with the placement of intracorneal rings |
Primary outcome
Best corrected visual acuity (BCVA) evolution. Visual acuity will be expressed in logMAR.
Time frame: 1 year
Evolution of the best corrected visual acuity (BCVA) 1 year after the installation of intra-corneal rings compared to the preoperative value. Visual acuity will be expressed in logMAR.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
Related trials for Intracorneal Ring
RecruitingObservational study
The Homburg Keratoconus Center (HKC)
Keratoconus
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?
An observational study of Intracorneal Ring and Keratoconus, run by Elsan at 1 site in France.
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 29 Mar 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 France. 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?
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?
Best corrected visual acuity (BCVA) evolution. Visual acuity will be expressed in logMAR. (time frame: 1 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 29 Mar 2024.