Rhegmatogenous Retinal DetachmentNCT01446367
Corneal Changes After Retinal Surgery
An observational study of Rhegmatogenous Retinal Detachment, run by Universidade Federal do Paraná.
Trial summary
The purpose of this study is to evaluate the corneal changes after performing 20 gauge vitrectomy associated with scleral buckling for the treatment of rhegmatogenous retinal detachment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rhegmatogenous Retinal Detachment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Feb 2011
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with rhegmatogenous retinal detachments
Who may be able to join
- Patients with rhegmatogenous retinal detachments
Who cannot join
- Previous eye surgery
About this study
Official title: Corneal Topographic Changes After 20-gauge Pars Plana Vitrectomy Associated With Scleral Buckling for the Treatment of Rhegmatogenous Retinal Detachment
The purpose of this study is to evaluate the corneal changes after performing 20 gauge vitrectomy associated with scleral buckling for the treatment of rhegmatogenous retinal detachment.
Read the detailed description
Patients submitted to 20-gauge vitrectomy associated with scleral buckling were evaluated with corneal topography before surgery and in the 7,30 and 90 days after surgery to asses corneal curvature changes.
- Conditions
- Rhegmatogenous Retinal Detachment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011
- Study completionFeb 2011
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 Rhegmatogenous Retinal DetachmentStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Grandinetti, Universidade Federal do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446367
- Sponsor's protocol ID
- Cornea vs Vit-buckle
- Status last verified
- Oct 2011
- First submitted
- 3 Oct 2011
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Weinberger D, Lichter H, Loya N, Axer-Siegel R, Muzmacher L, Gabbay U, Yassur Y. Corneal topographic changes after retinal and vitreous surgery. Ophthalmology. 1999 Aug;106(8):1521-4. doi: 10.1016/S0161-6420(99)90447-5.
PubMed 10442898
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Topographic Changes After 20-gauge Pars Plana Vitrectomy Associated With Scleral Buckling for the Treatment of Rhegmatogenous Retinal Detachment
- ClinicalTrials.gov ID
- NCT01446367
- Acronym / sponsor ID
- Cornea vs Vit-buckle
- Conditions
- Rhegmatogenous Retinal Detachment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universidade Federal do ParanáUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 5 Oct 2011 (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.
The purpose of this study is to evaluate the corneal changes after performing 20 gauge vitrectomy associated with scleral buckling for the treatment of rhegmatogenous retinal detachment.
Detailed description
Patients submitted to 20-gauge vitrectomy associated with scleral buckling were evaluated with corneal topography before surgery and in the 7,30 and 90 days after surgery to asses corneal curvature changes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rhegmatogenous retinal detachments
Key inclusion criteria (1 listed)
- Patients with rhegmatogenous retinal detachments
Key exclusion criteria (1 listed)
- Previous eye surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 5 Oct 2011.
- Background: PubMed 10442898Weinberger D, Lichter H, Loya N, Axer-Siegel R, Muzmacher L, Gabbay U, Yassur Y. Corneal topographic changes after retinal and vitreous surgery. Ophthalmology. 1999 Aug;106(8):1521-4. doi: 10.1016/S0161-6420(99)90447-5.
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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?
An observational study of Rhegmatogenous Retinal Detachment, run by Universidade Federal do Paraná.
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 5 Oct 2011. 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 NCT01446367, 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 5 Oct 2011.