Macular PsudoholeNCT01959802
Foveal Cone Outer Segment Tips Line Defect in Macular Pseudohole
A study testing Vitrectomy in people with Macular Psudohole, run by Kyorin University at 1 site in Japan.
Trial summary
Evaluation of recovery in foveal cone outer segment tips line defect and visual acuity after surgery for macular pseudohole Read more about this study
- Who is it for?
- Ages 10 to 95 years
- Conditions the study is for
- Macular Psudohole
- 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
- 22 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2008to 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 10 to 95 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patienst with macular pseudo hole
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: Correlation Between Foveal Cone Outer Segment Tips Line Defect and Visual Acuity After Surgery for Macular Pseudohole
Evaluation of recovery in foveal cone outer segment tips line defect and visual acuity after surgery for macular pseudohole
- Conditions
- Macular Psudohole
- Being tested
- Vitrectomy
- Keywords
- Macular pseudohole, Cone outer segment tips line
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Vitrectomy | Other | Vitrectomy for macular pseudo hole Receives: Procedure: Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optical coherence tomography
Anatomical recovery detected with optical coherence tomography after surgery
Measured: one year
Secondary outcomes (1)
Visual acuity
Visual recovery after surgery
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 posted10 Oct 2013 (estimated)
- Study startApr 2008
- Primary completionApr 2008
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular PsudoholeStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT01959802
- Sponsor's protocol ID
- Kyorineye014
- Other IDs
- Kyorineye014
- Status last verified
- Oct 2013
- First submitted
- 7 Oct 2013
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Foveal Cone Outer Segment Tips Line Defect and Visual Acuity After Surgery for Macular Pseudohole
- ClinicalTrials.gov ID
- NCT01959802
- Acronym / sponsor ID
- Kyorineye014
- Conditions
- Macular Psudohole
- Keywords
- Macular pseudohole, Cone outer segment tips line
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 10 Oct 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.
Evaluation of recovery in foveal cone outer segment tips line defect and visual acuity after surgery for macular pseudohole
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitrectomy | Other | Procedure: VitrectomyVitrectomy for macular pseudo hole |
Who may qualify
- Ages
- 10 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The patienst with macular pseudo hole
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 | Procedure or surgery | Vitrectomy |
Primary outcome
Optical coherence tomography
Time frame: one year
Anatomical recovery detected with optical coherence tomography after surgery
1 secondary outcome
Visual acuity
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 10 Oct 2013.
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 Macular Psudohole, 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 10 Oct 2013. 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 10 Oct 2013.