Macular HolesNCT01306487
Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery
An observational study of Macular Holes, run by Kyorin University at 1 site in Japan.
Trial summary
The objective is to determine whether a recovery of the microstructures of the foveal photoreceptors after macular hole (MH) closure is correlated with the best-corrected visual acuity (BCVA) is determined. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Macular Holes
- What is being tested?
- Vitrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2008to Aug 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients with surgically-closed MHs after successful vitrectomy
Who may be able to join
- The patients had undergone surgery from March 2008 to August 2009 at Kyorin Eye Center
- Idiopathic macular hole patients with either a Stage 2, 3, or 4 according to the Gass classification
Who cannot join
- The presence of other retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy
- High myopia with an axial length > 27.0 mm or refractive error > -8.0 diopters
- The patients followed for less than 6 months postoperatively
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Visual Acuity and Recovery of Foveal Cone Microstructures After Macular Hole Surgery
The objective is to determine whether a recovery of the microstructures of the foveal photoreceptors after macular hole (MH) closure is correlated with the best-corrected visual acuity (BCVA) is determined.
Read the detailed description
Macular hole patients were evaluated by spectral domain optical coherence tomography (SD-OCT) to determine the integrity of the microstructures of the foveal photoreceptors. The inner segment/outer segment (IS/OS) junction, the external limiting membrane (ELM), and the cone outer segment tips (COST) line were determined preoperatively, and at 1, 3, 6, 9, and 12 months after the MH surgery. The correlation between the integrity of the foveal photoreceptor microstructures and the best-corrected visual acuity (BCVA) was determined.
- Conditions
- Macular Holes
- Being tested
- Vitrectomy
- 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.
VitrectomyProcedure or surgery
Also called Optical coherence tomography
Macular hole surgery
| Study group | Role | What they receive |
|---|---|---|
| Macular hole patients | The patients who underwent vitreous surgery for idiopathic macular hole. Receives: Procedure: Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foveal microstructure determined by optical coherence tomography
The integrity of the microstructures of the foveal photoreceptors; the inner segment/outer segment (IS/OS) junction, the external limiting membrane (ELM), and the cone outer segment tips (COST) line were determined by spectral domain optical coherence tomography.
Measured: Preoperative and postoperative 1, 3, 6, 9, 12 months
Secondary outcomes (1)
The visual acuity
Preoperative and postoperative best-corrected visual acuity
Measured: Preoperative and postoperative 1, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startMar 2008
- Primary completionAug 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HolesStudies 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyorin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makoto Inoue, Kyorin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306487
- Sponsor's protocol ID
- Kyorineye002
- Status last verified
- Jul 2012
- First submitted
- 1 Mar 2011
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Visual Acuity and Recovery of Foveal Cone Microstructures After Macular Hole Surgery
- ClinicalTrials.gov ID
- NCT01306487
- Acronym / sponsor ID
- Kyorineye002
- Conditions
- Macular Holes
- Keywords
- macular hole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 2 Mar 2011 (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 objective is to determine whether a recovery of the microstructures of the foveal photoreceptors after macular hole (MH) closure is correlated with the best-corrected visual acuity (BCVA) is determined.
Detailed description
Macular hole patients were evaluated by spectral domain optical coherence tomography (SD-OCT) to determine the integrity of the microstructures of the foveal photoreceptors. The inner segment/outer segment (IS/OS) junction, the external limiting membrane (ELM), and the cone outer segment tips (COST) line were determined preoperatively, and at 1, 3, 6, 9, and 12 months after the MH surgery. The correlation between the integrity of the foveal photoreceptor microstructures and the best-corrected visual acuity (BCVA) was determined.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Macular hole patients | – | Procedure: VitrectomyThe patients who underwent vitreous surgery for idiopathic macular hole. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients with surgically-closed MHs after successful vitrectomy
Key inclusion criteria (2 listed)
- The patients had undergone surgery from March 2008 to August 2009 at Kyorin Eye Center
- Idiopathic macular hole patients with either a Stage 2, 3, or 4 according to the Gass classification
Key exclusion criteria (3 listed)
- The presence of other retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy
- High myopia with an axial length > 27.0 mm or refractive error > -8.0 diopters
- The patients followed for less than 6 months postoperatively
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: Optical coherence tomographyMacular hole surgery | Procedure or surgery | Macular hole patients |
Primary outcome
Foveal microstructure determined by optical coherence tomography
Time frame: Preoperative and postoperative 1, 3, 6, 9, 12 months
The integrity of the microstructures of the foveal photoreceptors; the inner segment/outer segment (IS/OS) junction, the external limiting membrane (ELM), and the cone outer segment tips (COST) line were determined by spectral domain optical coherence tomography.
1 secondary outcome
The visual acuity
Time frame: Preoperative and postoperative 1, 3, 6, 9, 12 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 2 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.
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 Holes, 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 2 inclusion and 3 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 2 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?
Foveal microstructure determined by optical coherence tomography (time frame: Preoperative and postoperative 1, 3, 6, 9, 12 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 2 Aug 2012.