Macular Hole SurgeryNCT02650739
Optical Coherence Tomography-based Positioning for Macular Hole Surgery
An observational study of Macular Hole Surgery, run by Kyorin University.
Trial summary
The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared with the surgery by the surgeon's decision. The macular hole closure and visual outcome were compared. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Macular Hole Surgery
- What is being tested?
- Macular hole surgery
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- May 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: The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images in 60 eyes was compared with the 69 eyes with same surgical procedure but the prone position determined by the surgeon's decision.
Who may be able to join
- The patients were followed more than 2 months.
Who cannot join
- Eye with axial length more than 26.0 mm
About this study
Official title: Duration of Prone Positioning After Macular Hole Surgery Determined by Swept Source Optical Coherence Tomography
The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared with the surgery by the surgeon's decision. The macular hole closure and visual outcome were compared.
Read the detailed description
The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared with the surgery by the surgeon's decision. All eyes were treated by pars plana vitrectomy, internal limiting membrane peeling, and gas tamponade. MH closure was defined as a connection of the edges of the sensory retina in the SS-OCT images.The macular hole closure and visual outcome were compared.
- Conditions
- Macular Hole Surgery
- Being tested
- Macular hole surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macular hole surgeryProcedure or surgery
Also called Vitrectomy
Vitrectomy with internal limiting membrane removal and gas tamponade
| Study group | Role | What they receive |
|---|---|---|
| SS-OCTdetermined group | Eyes with macular hole surgery that the postoperative prone positioning was discontinued after detecting a closure by SS-OCT Receives: Procedure: Macular hole surgery | |
| Control group | Eyes with macular hole surgery that the halting of the prone position was determined by the surgeon Receives: Procedure: Macular hole surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular hole closure
Closure of macular hole
Measured: Changes from baseline to 1, 2 months
Secondary outcomes (1)
Visual acuity before and after surgery
Vision
Measured: Changes from baseline to 1, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startMay 2013
- Primary completionAug 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 Hole SurgeryStudies 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
- 125 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
- NCT02650739
- Sponsor's protocol ID
- Kyorineye0021
- Status last verified
- Jan 2016
- First submitted
- 6 Jan 2016
- Last updated
- 8 Jan 2016
- 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 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Prone Positioning After Macular Hole Surgery Determined by Swept Source Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT02650739
- Acronym / sponsor ID
- Kyorineye0021
- Conditions
- Macular Hole Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Jan 2016 (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 efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared with the surgery by the surgeon's decision. The macular hole closure and visual outcome were compared.
Detailed description
The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared with the surgery by the surgeon's decision. All eyes were treated by pars plana vitrectomy, internal limiting membrane peeling, and gas tamponade. MH closure was defined as a connection of the edges of the sensory retina in the SS-OCT images.The macular hole closure and visual outcome were compared.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SS-OCTdetermined group | – | Procedure: Macular hole surgeryEyes with macular hole surgery that the postoperative prone positioning was discontinued after detecting a closure by SS-OCT |
| Control group | – | Procedure: Macular hole surgeryEyes with macular hole surgery that the halting of the prone position was determined by the surgeon |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images in 60 eyes was compared with the 69 eyes with same surgical procedure but the prone position determined by the surgeon's decision.
Key inclusion criteria (1 listed)
- The patients were followed more than 2 months.
Key exclusion criteria (1 listed)
- Eye with axial length more than 26.0 mm
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 |
|---|---|---|
| Macular hole surgeryAlso: VitrectomyVitrectomy with internal limiting membrane removal and gas tamponade | Procedure or surgery | Control group, SS-OCTdetermined group |
Primary outcome
Macular hole closure
Time frame: Changes from baseline to 1, 2 months
Closure of macular hole
1 secondary outcome
Visual acuity before and after surgery
Time frame: Changes from baseline to 1, 2 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 8 Jan 2016.
- 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.
Makoto Inoue, MD principal investigator
Kyorin Eye Center
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Hole Surgery, run by Kyorin University.
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 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Macular hole closure (time frame: Changes from baseline to 1, 2 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 8 Jan 2016.