CorneaNCT03127163
Intraestromal Corneal Ring in Mild Keratoconus
A study testing Intraestromal corneal ring in people with Cornea and Eye Diseases, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
To determine whether the implantation of an intrastromal corneal ring is an effective treatment for a homogeneous group of mild keratoconus patients. Read more about this study
- Who is it for?
- Ages 17 to 47 years
- Conditions the study is for
- Cornea, Eye Diseases, Keratoconus
- What is being tested?
- Intraestromal corneal ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jan 2015to 10 Jan 2017
- 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 17 to 47 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Investigators used the Amsler-Krumeich classification and included only patients classified as grade I or II.
Who cannot join
- Investigators excluded patients with central corneal scarring, with other eye disorders, or with previous ocular surgery. We also excluded patients with a history of herpes infection, keratitis, corneal dystrophies, diagnoses of autoimmune diseases, systemic connective tissue disorders, or acute keratoconus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrastromal Corneal Ring Was Effective for the Treatment of Mild Keratoconus
To determine whether the implantation of an intrastromal corneal ring is an effective treatment for a homogeneous group of mild keratoconus patients.
Read the detailed description
A group of 65 patients with mild keratoconus were implanted with a Ferrara ring in a single eye. Six months after surgery, the aberrations were measured and the visual function was determined using clinical indices. The aberrations, especially comatic aberration (coma), were measured independently.
- Conditions
- Cornea, Eye Diseases, Keratoconus, Ophthalmological Disorder
- Being tested
- Intraestromal corneal ring
- Medical subject headings
- Corneal Diseases, Eye Diseases, Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraestromal corneal ringDevice
Also called Ferrara ring
The patients underwent surgery to implant the intrastromal corneal ring (Ferrara Ophthalmics, Belo Horizonte, Brazil) using a manual technique. The procedures were performed by a single surgeon with extensive training in corneal surgery. All patients received the same ring, and the number (1 or 2 segments), thickness, and arc size were calculated using the nomogram provided by the manufacturer.
| Study group | Role | What they receive |
|---|---|---|
| Mild Keratoconus | Other | A group of 65 patients with keratoconus who were implanted with an intrastromal corneal ring; the group was composed of 40 males (61.50%) and 25 females (38.50%), with a mean age of 27.88 ± 7.38 years (range, 17-47 years). The patients were fully informed about the study and signed a consent form previously approved by the ethics committee of our institution.
We used the Amsler-Krumeich classification and included only patients classified as grade I or II. The investigators performed the intraestromal corneal ring surgery in the selected group. Receives: Device: Intraestromal corneal ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrations were measured and the visual function was determined using clinical indices.
Wave front data
Measured: 3 months after surgery
Secondary outcomes (2)
UCVA
Uncorrected visual acuity
Measured: 3 months after surgery
BCVA
Best corrected visual acuity
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start10 Jan 2015
- Primary completion10 Jan 2016
- Study completion10 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Intraestromal corneal ring
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mário Henrique Camargos de Lima, University of Sao Paulo
- Investigators
- Mário Lima, PhD, Principal investigator, São Paulo University investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127163
- Sponsor's protocol ID
- 0591/11
- Status last verified
- Apr 2017
- First submitted
- 12 Apr 2017
- Last updated
- 25 Apr 2017
- 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 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrastromal Corneal Ring Was Effective for the Treatment of Mild Keratoconus
- ClinicalTrials.gov ID
- NCT03127163
- Acronym / sponsor ID
- 0591/11
- Conditions
- Cornea, Eye Diseases, Keratoconus, Ophthalmological Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 10 Jan 2015 (actual)
- Primary completion
- 10 Jan 2016 (actual)
- Study completion
- 10 Jan 2017 (actual)
- First posted
- 25 Apr 2017 (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.
To determine whether the implantation of an intrastromal corneal ring is an effective treatment for a homogeneous group of mild keratoconus patients.
Detailed description
A group of 65 patients with mild keratoconus were implanted with a Ferrara ring in a single eye. Six months after surgery, the aberrations were measured and the visual function was determined using clinical indices. The aberrations, especially comatic aberration (coma), were measured independently.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intraestromal corneal ring
| Arm | Type | Receives |
|---|---|---|
| Mild Keratoconus | Other | Device: Intraestromal corneal ringA group of 65 patients with keratoconus who were implanted with an intrastromal corneal ring; the group was composed of 40 males (61.50%) and 25 females (38.50%), with a mean age of 27.88 ± 7.38 years (range, 17-47 years). The patients were fully informed about the study and signed a consent form previously approved by the ethics committee of our institution. We used the Amsler-Krumeich classification and included only patients classified as grade I or II. The investigators performed the intraestromal corneal ring surgery in the selected group. |
Who may qualify
- Ages
- 17 to 47 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Investigators used the Amsler-Krumeich classification and included only patients classified as grade I or II.
Key exclusion criteria (1 listed)
- Investigators excluded patients with central corneal scarring, with other eye disorders, or with previous ocular surgery. We also excluded patients with a history of herpes infection, keratitis, corneal dystrophies, diagnoses of autoimmune diseases, systemic connective tissue disorders, or acute keratoconus.
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 |
|---|---|---|
| Intraestromal corneal ringAlso: Ferrara ringThe patients underwent surgery to implant the intrastromal corneal ring (Ferrara Ophthalmics, Belo Horizonte, Brazil) using a manual technique. The procedures were performed by a single surgeon with extensive training in corneal surgery. All patients received the same ring, and the number (1 or 2 segments), thickness, and arc size were calculated using the nomogram provided by the manufacturer. | Device | Mild Keratoconus |
Primary outcome
Aberrations were measured and the visual function was determined using clinical indices.
Time frame: 3 months after surgery
Wave front data
2 secondary outcomes
UCVA
Time frame: 3 months after surgery
BCVA
Time frame: 3 months after surgery
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 25 Apr 2017.
- 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.
Mário Lima, PhD principal investigator
São Paulo University investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraestromal corneal ring in people with Cornea and Eye Diseases, run by University of Sao Paulo 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 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: finished, as of the sponsor's last update on 25 Apr 2017. 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?
Aberrations were measured and the visual function was determined using clinical indices. (time frame: 3 months after surgery). 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 Apr 2017.