Macular HoleNCT02628262
Fundus Autofluorescence After Macular Hole Surgery
An observational study of Macular Hole, run by Makoto Inoue at 1 site in Japan.
Trial summary
Funds autofluorescence (FAF) indicates hyper fluorescence at the macular hole in the patients with macular hole. Investigators investigate the association between FAF and visual acuity, recovery of foveal microstructure, and FAF in surgically closed macular holes. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Macular Hole
- What is being tested?
- Vitrectomy with internal limiting membrane removal and gas tamponade
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2013to Oct 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: Optos ultrawide angle FAF images were taken in 27 eyes before and after MH surgery and compared with swept source optical coherence tomographic (SS-OCT) images.
Who may be able to join
- The patients were followed more than 6 months.
Who cannot join
- The patient were followed less than 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fundus Autofluorescence Images in Gas-filled Eyes Immediately After Macular Hole Surgery
Funds autofluorescence (FAF) indicates hyper fluorescence at the macular hole in the patients with macular hole. Investigators investigate the association between FAF and visual acuity, recovery of foveal microstructure, and FAF in surgically closed macular holes.
Read the detailed description
Ultrawide angle FAF images were taken in 27 eyes before and after macular hole surgery and compared with swept source optical coherence tomographic (SS-OCT) images.
- Conditions
- Macular Hole
- Being tested
- Vitrectomy with internal limiting membrane removal and gas tamponade
- Keywords
- Macular hole
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrectomy with internal limiting membrane removal and gas tamponadeProcedure or surgery
Vitrectomy with internal limiting membrane removal and gas tamponade
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity before and after surgery
Vision
Measured: Changes from baseline to 1,3, 6 months
Secondary outcomes (1)
Fundus autofluorescence at the macula
Fundus autofluorescence at the macula
Measured: Changes from baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startApr 2013
- Primary completionApr 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HoleStudies 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
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makoto Inoue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Makoto Inoue, Kyorin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628262
- Sponsor's protocol ID
- Kyorineye020
- Status last verified
- Dec 2015
- First submitted
- 6 Dec 2015
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fundus Autofluorescence Images in Gas-filled Eyes Immediately After Macular Hole Surgery
- ClinicalTrials.gov ID
- NCT02628262
- Acronym / sponsor ID
- Kyorineye020
- Conditions
- Macular Hole
- Keywords
- Macular hole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Makoto InoueUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Dec 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.
Funds autofluorescence (FAF) indicates hyper fluorescence at the macular hole in the patients with macular hole. Investigators investigate the association between FAF and visual acuity, recovery of foveal microstructure, and FAF in surgically closed macular holes.
Detailed description
Ultrawide angle FAF images were taken in 27 eyes before and after macular hole surgery and compared with swept source optical coherence tomographic (SS-OCT) images.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Optos ultrawide angle FAF images were taken in 27 eyes before and after MH surgery and compared with swept source optical coherence tomographic (SS-OCT) images.
Key inclusion criteria (1 listed)
- The patients were followed more than 6 months.
Key exclusion criteria (1 listed)
- The patient were followed 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 internal limiting membrane removal and gas tamponadeVitrectomy with internal limiting membrane removal and gas tamponade | Procedure or surgery | – |
Primary outcome
Visual acuity before and after surgery
Time frame: Changes from baseline to 1,3, 6 months
Vision
1 secondary outcome
Fundus autofluorescence at the macula
Time frame: Changes from baseline up to 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 11 Dec 2015.
- Individual participant dataSharing planned: No
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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.
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, run by Makoto Inoue 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 11 Dec 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: Changes from baseline to 1,3, 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 11 Dec 2015.