HyperopiaNCT00917657
Photorefractive Keratectomy (PRK) for Hyperopia After Radial Keratotomy
A study testing Photorefractive keratectomy in people with Hyperopia, run by University of Sao Paulo.
Trial summary
To assess the efficacy, predictability, stability and safety of corneal wavefront-guided photorefractive keratectomy (PRK) for correcting hyperopia and astigmatism after radial keratotomy (RK). Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Hyperopia
- What is being tested?
- Photorefractive keratectomy
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Jun 2009
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hyperopia or hyperopic astigmatism with spherical equivalent of up to + 9,25 D and astigmatism of up to - 4,5 D;
- Uncorrected Visual Acuity of 20/40 or worse;
- Best-Corrected Visual Acuity of 20/60 or better.
Who cannot join
- Systemic or ocular conditions that could bias results
- Previous photorefractive surgery
About this study
Official title: Corneal Wavefront-Guided PRK With Adjunctive Mitomycin-C for the Treatment of Hyperopia After Radial Keratotomy
To assess the efficacy, predictability, stability and safety of corneal wavefront-guided photorefractive keratectomy (PRK) for correcting hyperopia and astigmatism after radial keratotomy (RK).
- Conditions
- Hyperopia
- Being tested
- Photorefractive keratectomy
- Keywords
- photorefractive keratectomy, hyperopia, radial keratotomy, refractive surgery
- Medical subject headings
- Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photorefractive keratectomyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startFeb 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperopiaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917657
- Sponsor's protocol ID
- 1183/07
- Status last verified
- Jun 2009
- First submitted
- 9 Jun 2009
- Last updated
- 10 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ghanem RC, Ghanem EA, Kara-Jose N. [Safety of photorefractive keratectomy with mitomycin-C for the treatment of hyperopia after radial keratotomy]. Arq Bras Oftalmol. 2010 Mar-Apr;73(2):165-70. doi: 10.1590/s0004-27492010000200013. Portuguese.
PubMed 20549047Ghanem RC, Ghanem EA, Kara-Jose N. [Corneal wavefront-guided photorefractive keratectomy with mitomycin-C for consecutive hyperopia after radial keratotomy]. Arq Bras Oftalmol. 2010 Jan-Feb;73(1):70-6. doi: 10.1590/s0004-27492010000100013. Portuguese.
PubMed 20464118
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Wavefront-Guided PRK With Adjunctive Mitomycin-C for the Treatment of Hyperopia After Radial Keratotomy
- ClinicalTrials.gov ID
- NCT00917657
- Acronym / sponsor ID
- 1183/07
- Conditions
- Hyperopia
- Keywords
- photorefractive keratectomy, hyperopia, radial keratotomy, refractive surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 10 Jun 2009 (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 assess the efficacy, predictability, stability and safety of corneal wavefront-guided photorefractive keratectomy (PRK) for correcting hyperopia and astigmatism after radial keratotomy (RK).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hyperopia or hyperopic astigmatism with spherical equivalent of up to + 9,25 D and astigmatism of up to - 4,5 D;
- Uncorrected Visual Acuity of 20/40 or worse;
- Best-Corrected Visual Acuity of 20/60 or better.
Key exclusion criteria (2 listed)
- Systemic or ocular conditions that could bias results
- Previous photorefractive surgery
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 |
|---|---|---|
| Photorefractive keratectomy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 10 Jun 2009.
- Derived from this study: PubMed 20549047Ghanem RC, Ghanem EA, Kara-Jose N. [Safety of photorefractive keratectomy with mitomycin-C for the treatment of hyperopia after radial keratotomy]. Arq Bras Oftalmol. 2010 Mar-Apr;73(2):165-70. doi: 10.1590/s0004-27492010000200013. Portuguese.
- Derived from this study: PubMed 20464118Ghanem RC, Ghanem EA, Kara-Jose N. [Corneal wavefront-guided photorefractive keratectomy with mitomycin-C for consecutive hyperopia after radial keratotomy]. Arq Bras Oftalmol. 2010 Jan-Feb;73(1):70-6. doi: 10.1590/s0004-27492010000100013. Portuguese.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Photorefractive keratectomy in people with Hyperopia, run by University of Sao Paulo.
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 10 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00917657, which also lists 2 linked publications.
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 10 Jun 2009.