Macular Hole Retinal DetachmentNCT02528045
Vitrectomy and Scleral Shortening for Macular Hole Retinal Detachment or Myopic Traction Maculopathy
An observational study of Macular Hole Retinal Detachment and Myopic Traction Maculopathy, run by Kyorin University at 1 site in Japan.
Trial summary
The medical records of 16 eyes of 16 patients with macular hole retinal detachment or myopic traction maculopathy who received viterctomy including internal limiting membrane peeling and scleral shorting surgery were reviewed. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Macular Hole Retinal Detachment, Myopic Traction Maculopathy
- What is being tested?
- Vitrectomy with scleral shortening
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2012to Jun 2015
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who underwent vitrectomy with scleral shortening for macular hole retinal detachment or myopic traction maculopathy
Who may be able to join
- The inclusion criteria were patients who had highly myopic eyes with macular hole retinal detachment to myopic traction maculopathy
Who cannot join
- The patients with follow-up less than 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Surgical Treatment of Vitrectomy and Scleral Shortening for Macular Hole Retinal Detachment or Myopic Traction Maculopathy
The medical records of 16 eyes of 16 patients with macular hole retinal detachment or myopic traction maculopathy who received viterctomy including internal limiting membrane peeling and scleral shorting surgery were reviewed. Best-corrected visual acuity, axial length, retinal reattachment and macular hole closure, the shape of staphyloma determined by optical coherence tomography and 3-dimensional magnetic resonance imaging were assessed.
- Being tested
- Vitrectomy with scleral shortening
- Keywords
- Myopic traction maculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrectomy with scleral shorteningProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity before and after surgery
Comparison with logarithm of Minimum Angle of Resolution (logMAR) vision
Measured: 6 months
Secondary outcomes (1)
Retinal reattachment
Retinal reattachment or resolution of myopic traction maculopathy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startJun 2012
- Primary completionJul 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Hole 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 only
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyorin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makoto Inoue, Kyorin University
- Investigators
- Akito Hirakata, MD, Principal investigator, Kyorin Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528045
- Sponsor's protocol ID
- Kyorineye017
- Status last verified
- Aug 2015
- First submitted
- 16 Aug 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Surgical Treatment of Vitrectomy and Scleral Shortening for Macular Hole Retinal Detachment or Myopic Traction Maculopathy
- ClinicalTrials.gov ID
- NCT02528045
- Acronym / sponsor ID
- Kyorineye017
- Keywords
- Myopic traction maculopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Aug 2015 (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 medical records of 16 eyes of 16 patients with macular hole retinal detachment or myopic traction maculopathy who received viterctomy including internal limiting membrane peeling and scleral shorting surgery were reviewed. Best-corrected visual acuity, axial length, retinal reattachment and macular hole closure, the shape of staphyloma determined by optical coherence tomography and 3-dimensional magnetic resonance imaging were assessed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who underwent vitrectomy with scleral shortening for macular hole retinal detachment or myopic traction maculopathy
Key inclusion criteria (1 listed)
- The inclusion criteria were patients who had highly myopic eyes with macular hole retinal detachment to myopic traction maculopathy
Key exclusion criteria (1 listed)
- The patients with follow-up less than 6 months
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 |
|---|---|---|
| Vitrectomy with scleral shortening | Procedure or surgery | – |
Primary outcome
Visual acuity before and after surgery
Time frame: 6 months
Comparison with logarithm of Minimum Angle of Resolution (logMAR) vision
1 secondary outcome
Retinal reattachment
Time frame: 6 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 19 Aug 2015.
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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.
Akito Hirakata, MD principal investigator
Kyorin Eye Center
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 Macular Hole Retinal Detachment and Myopic Traction Maculopathy, run by Kyorin University at 1 site in Japan.
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 19 Aug 2015. 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 Japan. 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?
Visual acuity before and after surgery (time frame: 6 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 19 Aug 2015.