MaculopathyNCT01658761
Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes
A study testing vitrectomy in people with Maculopathy and High Myopia, run by Kyorin University at 1 site in Japan.
Trial summary
Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was evaluated in each stage. Efficacy of internal limiting membrane was also evaluated whether it may improve visual outcome. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Maculopathy, High Myopia, Surgery
- What is being tested?
- vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteJapan
- Study dates
- Sep 1998to Mar 2012
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eyes with myopic traction maculopathy in highly myopic eyes with refractive errors ≤ -8.0 diopters and axial length ≥ 26.0 mm who underwent vitrectomy
Who cannot join
- Eyes with follow-up less than a year
Trial locations and contacts
1 site in 1 country.
About this study
Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was evaluated in each stage. Efficacy of internal limiting membrane was also evaluated whether it may improve visual outcome.
Read the detailed description
Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was evaluated in each stage of macular retinischisis, foveal detachment, or macular hole. Efficacy of internal limiting membrane was also evaluated whether it may improve visual outcome.
- Conditions
- Maculopathy, High Myopia, Surgery
- Being tested
- vitrectomy
- Keywords
- Myopic traction maculopathy, vitrectomy, internal limiting membrane, Retrospective, case control study
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitrectomyProcedure or surgery
Also called Myopic traction maculopathy in highly myopic eyes
Surgery
| Study group | Role | What they receive |
|---|---|---|
| Myopic traction maculopathy | Experimental | The 71 eyes of 64 patients (14 men and 50 women) with myopic traction maculopathy in highly myopic eyes (refractive errors ≤-8.0 diopters and axial length ≥26.0 mm) who underwent vitrectomy were retrospectively reviewed. Receives: Procedure: vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Preoperative and postoperative visual acuity
Measured: One year
Secondary outcomes (1)
Optical coherence tomography
Anatomical retinal images by optical cohernce tomography
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startSep 1998
- Primary completionFeb 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MaculopathyStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyorin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makoto Inoue, Kyorin University
- Investigators
- Makoto Inoue, MD, Principal investigator, Kyorin Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658761
- Sponsor's protocol ID
- KyorinEye008
- Other IDs
- Myopic maculopathy
- Status last verified
- Aug 2012
- First submitted
- 28 Jul 2012
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes
- ClinicalTrials.gov ID
- NCT01658761
- Acronym / sponsor ID
- KyorinEye008
- Conditions
- Maculopathy, High Myopia, Surgery
- Keywords
- Myopic traction maculopathy, vitrectomy, internal limiting membrane, Retrospective, case control study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Study start
- Sep 1998
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 7 Aug 2012 (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.
Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was evaluated in each stage. Efficacy of internal limiting membrane was also evaluated whether it may improve visual outcome.
Detailed description
Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was evaluated in each stage of macular retinischisis, foveal detachment, or macular hole. Efficacy of internal limiting membrane was also evaluated whether it may improve visual outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myopic traction maculopathy | Experimental | Procedure: vitrectomyThe 71 eyes of 64 patients (14 men and 50 women) with myopic traction maculopathy in highly myopic eyes (refractive errors ≤-8.0 diopters and axial length ≥26.0 mm) who underwent vitrectomy were retrospectively reviewed. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eyes with myopic traction maculopathy in highly myopic eyes with refractive errors ≤ -8.0 diopters and axial length ≥ 26.0 mm who underwent vitrectomy
Key exclusion criteria (1 listed)
- Eyes with follow-up less than a year
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 |
|---|---|---|
| vitrectomyAlso: Myopic traction maculopathy in highly myopic eyesSurgery | Procedure or surgery | Myopic traction maculopathy |
Primary outcome
Visual acuity
Time frame: One year
Preoperative and postoperative visual acuity
1 secondary outcome
Optical coherence tomography
Time frame: One year
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 7 Aug 2012.
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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.
Makoto Inoue, 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?
A study testing vitrectomy in people with Maculopathy and High Myopia, 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 7 Aug 2012. 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 (time frame: One year). 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 7 Aug 2012.