Radial Keratotomy in Keratoconus CasesNCT01879631
Efficacy of Radial Keratotomy in the Optical Rehabilitation of Mild to Moderate Keratoconus Cases
An observational study of Radial Keratotomy in Keratoconus Cases, run by Nisa Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
Keratoconus is a progressive ectatic disorder that steepens the cornea resulting in a conical shape. Radial Keratotomy can provide an optical rehabilitation by its flattening effect. It can also halt the progression of disease owing to fibrotic activation in perpendicular corneal incisions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Keratotomy in Keratoconus Cases
- What is being tested?
- radial keratotomy
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2012to Dec 2012
- 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: mild to moderate keratoconus cases
Who may be able to join
- keratoconus with a central corneal thickness (CCT) over 400µm,
- poor corrected visual acuity (≤0.4 at Snellen visual acuity charts),
- contact lens intolerance
Who cannot join
- apical scarring,
- ocular or systemic problem other than keratoconus
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ophthalmology Department, Nisa Hospital
Istanbul, 34196
About this study
Keratoconus is a progressive ectatic disorder that steepens the cornea resulting in a conical shape. Radial Keratotomy can provide an optical rehabilitation by its flattening effect. It can also halt the progression of disease owing to fibrotic activation in perpendicular corneal incisions.
- Conditions
- Radial Keratotomy in Keratoconus Cases
- Being tested
- radial keratotomy
- Keywords
- radial keratotomy; keratoconus; optical rehabilitation
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radial keratotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| mild to moderate keratoconus cases | keratoconus with a central corneal thickness (CCT) over 400µm, poor corrected visual acuity (≤0.4 at Snellen visual acuity charts), contact lens intolerance, no apical scarring, no ocular or systemic problem other than keratoconus Receives: Procedure: radial keratotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
outcome measures: uncorrected and best spectacle corrected visual acuity, keratometer readings
Preoperative and postoperative uncorrected visual acuity, best spectacle corrected visual acuity, and keratometer readings will be reviewed retrospectively. As reviewed follow up time range is 12 to 52 months, time frame is assessed as " 12 to 52 months"
Measured: after surgery - 12 to 52 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startJul 2012
- Primary completionNov 2012
- Study completionDec 2012
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 Radial Keratotomy in Keratoconus CasesStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nisa Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Kocak, Nisa Hastanesi
- Investigators
- ibrahim kocak, m.d, Principal investigator, ophthalmologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879631
- Sponsor's protocol ID
- B.30.2.IMU.0.05.05-11
- Other IDs
- B32IMU0050511
- Status last verified
- Jun 2013
- First submitted
- 11 Jun 2013
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Utine CA, Bayraktar S, Kaya V, Kucuksumer Y, Eren H, Perente I, Yilmaz OF. Radial keratotomy for the optical rehabilitation of mild to moderate keratoconus: more than 5 years' experience. Eur J Ophthalmol. 2006 May-Jun;16(3):376-84.
PubMed 16761238
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Radial Keratotomy in the Optical Rehabilitation of Mild to Moderate Keratoconus Cases
- ClinicalTrials.gov ID
- NCT01879631
- Acronym / sponsor ID
- B.30.2.IMU.0.05.05-11
- Conditions
- Radial Keratotomy in Keratoconus Cases
- Keywords
- radial keratotomy; keratoconus; optical rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Nisa HastanesiUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Jun 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.
Keratoconus is a progressive ectatic disorder that steepens the cornea resulting in a conical shape. Radial Keratotomy can provide an optical rehabilitation by its flattening effect. It can also halt the progression of disease owing to fibrotic activation in perpendicular corneal incisions.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mild to moderate keratoconus cases | – | Procedure: radial keratotomykeratoconus with a central corneal thickness (CCT) over 400µm, poor corrected visual acuity (≤0.4 at Snellen visual acuity charts), contact lens intolerance, no apical scarring, no ocular or systemic problem other than keratoconus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mild to moderate keratoconus cases
Key inclusion criteria (3 listed)
- keratoconus with a central corneal thickness (CCT) over 400µm,
- poor corrected visual acuity (≤0.4 at Snellen visual acuity charts),
- contact lens intolerance
Key exclusion criteria (2 listed)
- apical scarring,
- ocular or systemic problem other than 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 |
|---|---|---|
| radial keratotomy | Procedure or surgery | mild to moderate keratoconus cases |
Primary outcome
outcome measures: uncorrected and best spectacle corrected visual acuity, keratometer readings
Time frame: after surgery - 12 to 52 months
Preoperative and postoperative uncorrected visual acuity, best spectacle corrected visual acuity, and keratometer readings will be reviewed retrospectively. As reviewed follow up time range is 12 to 52 months, time frame is assessed as " 12 to 52 months"
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 18 Jun 2013.
- Results publication: PubMed 16761238Utine CA, Bayraktar S, Kaya V, Kucuksumer Y, Eren H, Perente I, Yilmaz OF. Radial keratotomy for the optical rehabilitation of mild to moderate keratoconus: more than 5 years' experience. Eur J Ophthalmol. 2006 May-Jun;16(3):376-84.
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.
ibrahim kocak, m.d principal investigator
ophthalmologist
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 Radial Keratotomy in Keratoconus Cases, run by Nisa Hastanesi at 1 site in Turkey (Türkiye).
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 3 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 18 Jun 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 Turkey (Türkiye). 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?
outcome measures: uncorrected and best spectacle corrected visual acuity, keratometer readings (time frame: after surgery - 12 to 52 months). 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 NCT01879631, 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 18 Jun 2013.