Macular RetinoschisisNCT01862627
Macular Retinoschisis and Detachment Associated With Glaucomatous Optic Neuropathy
An observational study of Macular Retinoschisis and Macular Detachment, run by Kyorin University at 1 site in Japan.
Trial summary
Clinical features, optical coherence tomography findings and surgical outcome in eyes with macular retinoschisis and detachment with normal tension glaucoma but without optic disc pit or high myopia were evaluated. Read more about this study
- Who is it for?
- Ages 10 to 95 years
- Conditions the study is for
- Macular Retinoschisis, Macular Detachment, Normal Tension Glaucoma
- What is being tested?
- Optical coherence tomography
- Type of treatment
- Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2004to Apr 2013
- 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 10 to 95 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients with macular retinoschisis and detachment associated with normal tension glaucoma
Who may be able to join
- The patients with macular retinoschisis and detachment associated with normal tension glaucoma
Who cannot join
- Optic pit maculopathy, high myopia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Macular Retinoschisis and Detachment Associated With Glaucomatous Optic Neuropathy But Without Optic Disc Pit Nor High Myopia
Clinical features, optical coherence tomography findings and surgical outcome in eyes with macular retinoschisis and detachment with normal tension glaucoma but without optic disc pit or high myopia were evaluated.
- Being tested
- Optical coherence tomography
- Keywords
- Macular retinoschisis, Macular detachment, vitrectomy
- Medical subject headings
- Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Macular retinoschisis and detachment | Not described Receives: Procedure: Optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optical coherence tomography
Anatomical improvement detected with optical coherence tomography after surgical intervention.
Measured: One year
Secondary outcomes (1)
Visual recovery
The number of the patients with visual recovery after surgical intervention
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 posted24 May 2013 (estimated)
- Study startDec 2004
- Primary completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular RetinoschisisStudies 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
- 11 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
- NCT01862627
- Sponsor's protocol ID
- Kyorineye011
- Status last verified
- Aug 2014
- First submitted
- 15 May 2013
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Retinoschisis and Detachment Associated With Glaucomatous Optic Neuropathy But Without Optic Disc Pit Nor High Myopia
- ClinicalTrials.gov ID
- NCT01862627
- Acronym / sponsor ID
- Kyorineye011
- Keywords
- Macular retinoschisis, Macular detachment, vitrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Apr 2013 (actual)
- First posted
- 24 May 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.
Clinical features, optical coherence tomography findings and surgical outcome in eyes with macular retinoschisis and detachment with normal tension glaucoma but without optic disc pit or high myopia were evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Macular retinoschisis and detachment | – | Procedure: Optical coherence tomography |
Who may qualify
- Ages
- 10 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients with macular retinoschisis and detachment associated with normal tension glaucoma
Key inclusion criteria (1 listed)
- The patients with macular retinoschisis and detachment associated with normal tension glaucoma
Key exclusion criteria (1 listed)
- Optic pit maculopathy, high myopia
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 |
|---|---|---|
| Optical coherence tomography | Procedure or surgery | Macular retinoschisis and detachment |
Primary outcome
Optical coherence tomography
Time frame: One year
Anatomical improvement detected with optical coherence tomography after surgical intervention.
1 secondary outcome
Visual recovery
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 20 Aug 2014.
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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?
An observational study of Macular Retinoschisis and Macular Detachment, 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 20 Aug 2014. 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?
Optical coherence tomography (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 20 Aug 2014.