EctasiaNCT02008253
Intrastromal Corneal Ring for Ectasia After Refractive Surgery (Anel)
An observational study of Ectasia, run by Instituto de Olhos de Goiania at 1 site in Brazil.
Trial summary
To evaluate the clinical outcomes of intrastromal corneal ring segment (ICRS) implantation to correct keratoconus on eyes with prior refractive surgery. Read more about this study
- Who is it for?
- Ages 19 to 48 years
- Conditions the study is for
- Ectasia
- What is being tested?
- INTRASTROMAL CORNEAL RING SEGMENT
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2010to Nov 2013
- 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 19 to 48 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients residents in Brazil with ectasia after refractive surgery
Who may be able to join
- Patients 19 to 48 years old
- Keratoconus (ectasia) on eyes with prior refractive surgery
Who cannot join
- Diabetes
- Autoimmune diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrastromal Corneal Ring Segment Implantation for Ectasia After Refractive Surgery
To evaluate the clinical outcomes of intrastromal corneal ring segment (ICRS) implantation to correct keratoconus on eyes with prior refractive surgery.
Read the detailed description
Forty-two eyes of 26 patients, 14 men and 12 women, with ectasia after refractive surgery were studied in a nonrandomized, retrospective, observational case series. Mean age at the time of ICRS implantation was 30,5 years.
- Conditions
- Ectasia
- Being tested
- INTRASTROMAL CORNEAL RING SEGMENT
- Keywords
- INTRASTROMAL CORNEAL RING, ASTIGMATISM
- Medical subject headings
- Dilatation, Pathologic, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTRASTROMAL CORNEAL RING SEGMENTProcedure or surgery
Corneal tunnels were created by means of mechanical dissection in all eyes. Main outcome measures included UCVA, BCVA, refraction, keratometry and computerized analysis of corneal topography.
| Study group | Role | What they receive |
|---|---|---|
| INTRASTROMAL CORNEAL RING SEGMENT | Forty-two eyes of 26 patients, 14 men and 12 women, with ectasia after refractive surgery were studied in a nonrandomized, retrospective, observational case series. Receives: Procedure: INTRASTROMAL CORNEAL RING SEGMENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrastromal Corneal Ring Segment Implantation for Ectasia After Refractive Surgery
To evaluate the clinical outcomes of intrastromal corneal ring segment (ICRS) implantation to correct keratoconus on eyes with prior refractive surgery. Corneal tunnels were created by means of mechanical dissection in all eyes. Main outcome measures included UCVA, BCVA, refraction, keratometry and computerized analysis of corneal topography.
Measured: Mean follow-up after ICRS implantation was 12 months (range, 09 to 22 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startApr 2010
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EctasiaStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Olhos de Goiania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Larissa Rossana S Stival, Study chair, Instituto de Olhos de Goiânia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008253
- Sponsor's protocol ID
- BQ-1-14 - ARVO
- Status last verified
- Dec 2013
- First submitted
- 1 Dec 2013
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrastromal Corneal Ring Segment Implantation for Ectasia After Refractive Surgery
- ClinicalTrials.gov ID
- NCT02008253
- Acronym / sponsor ID
- BQ-1-14 - ARVO
- Conditions
- Ectasia
- Keywords
- INTRASTROMAL CORNEAL RING, ASTIGMATISM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Instituto de Olhos de GoianiaUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 11 Dec 2013 (estimated)
- 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.
To evaluate the clinical outcomes of intrastromal corneal ring segment (ICRS) implantation to correct keratoconus on eyes with prior refractive surgery.
Detailed description
Forty-two eyes of 26 patients, 14 men and 12 women, with ectasia after refractive surgery were studied in a nonrandomized, retrospective, observational case series. Mean age at the time of ICRS implantation was 30,5 years.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INTRASTROMAL CORNEAL RING SEGMENT | – | Procedure: INTRASTROMAL CORNEAL RING SEGMENTForty-two eyes of 26 patients, 14 men and 12 women, with ectasia after refractive surgery were studied in a nonrandomized, retrospective, observational case series. |
Who may qualify
- Ages
- 19 to 48 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients residents in Brazil with ectasia after refractive surgery
Key inclusion criteria (2 listed)
- Patients 19 to 48 years old
- Keratoconus (ectasia) on eyes with prior refractive surgery
Key exclusion criteria (2 listed)
- Diabetes
- Autoimmune 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 |
|---|---|---|
| INTRASTROMAL CORNEAL RING SEGMENTCorneal tunnels were created by means of mechanical dissection in all eyes. Main outcome measures included UCVA, BCVA, refraction, keratometry and computerized analysis of corneal topography. | Procedure or surgery | INTRASTROMAL CORNEAL RING SEGMENT |
Primary outcome
Intrastromal Corneal Ring Segment Implantation for Ectasia After Refractive Surgery
Time frame: Mean follow-up after ICRS implantation was 12 months (range, 09 to 22 months).
To evaluate the clinical outcomes of intrastromal corneal ring segment (ICRS) implantation to correct keratoconus on eyes with prior refractive surgery. Corneal tunnels were created by means of mechanical dissection in all eyes. Main outcome measures included UCVA, BCVA, refraction, keratometry and computerized analysis of corneal topography.
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 11 Dec 2013.
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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.
Larissa Rossana S Stival study chair
Instituto de Olhos de Goiânia
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 Ectasia, run by Instituto de Olhos de Goiania at 1 site in Brazil.
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 2 inclusion and 2 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 11 Dec 2013. 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 Brazil. 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?
Intrastromal Corneal Ring Segment Implantation for Ectasia After Refractive Surgery (time frame: Mean follow-up after ICRS implantation was 12 months (range, 09 to 22 months).). 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 11 Dec 2013.