Macular HolesNCT01687829
Macular Hole Surgery With and Without Internal Limiting Membrane Peeling：A Systematic Review and Meta-analysis
An observational study of Macular Holes, run by Yifan Feng at 1 site in China.
Trial summary
Since Kelly and Wendel first reported successful closure of idiopathic macular holes (MH) by vitrectomy in 1991, many surgical modifications have been made to improve the anatomical and visual outcomes of this surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Macular Holes
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to May 2014
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients were scheduled to undergo macular hole surgery and randomized to with and without internal limiting membrane (ILM) peeling
Who may be able to join
- Eligible participants are those with idiopathic FTMH in stages 2-3, of less or equal than 18 months duration (based on symptoms reported by the patient) and with a visual acuity equal to or worse than 20/40 in the study eye.
Who cannot join
- Patients with idiopathic FTMH stages 2-3 but longer than 18 months duration or with other causes of decreased vision (e.g. corneal scarring, age-related macular degeneration, diabetic retinopathy, glaucoma if central and/or paracentral absolute visual field defects are present) and
- Those with FTMH related to high myopia (> 6 dioptres) or trauma will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wenzhou Medical College
Wenzhou, Zhejiang, 325000
Yifan Feng, MD, +86-577-88068880, wzafengyifan@163.com
Yifan Feng, MD
About this study
Since Kelly and Wendel first reported successful closure of idiopathic macular holes (MH) by vitrectomy in 1991, many surgical modifications have been made to improve the anatomical and visual outcomes of this surgery. Recently, internal limiting membrane (ILM) peeling has become used widely as an adjunctive procedure during MH surgery because the removal of ILM is thought to reduce the tangential traction on the macula, a major factor in the pathogenesis of idiopathic macular holes. However, the role of ILM peeling in macular hole surgery is not yet well defined. To the best of our knowledge, there is no meta-analysis on comparison of the efficacy of ILM peeling and suture for MH surgery. This study reviewed the published literature comparing surgical results with and without ILM peeling and and performed a meta-analysis to determine whether there is any benefit or detriment anatomically and/or visually.
- Conditions
- Macular Holes
- Keywords
- Macular Holes, Internal limiting membrane, peeling, Surgery
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ILM-on group | patients were scheduled to undergo macular hole surgery without internal limiting membrane (ILM) peeling | |
| ILM-off group | patients were scheduled to undergo macular hole surgery with internal limiting membrane (ILM) peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic Success rate
Anatomic success defined as a closed hole without a visible edge or a flat hole without a rim of subretinal fluid.
Measured: 12 months
Functional Success Rate
Functional Success defined as an improvement of 2 or more Snellen BCVA.
Measured: 12 month
Secondary outcomes (2)
Best-corrected visual acuity
All Snellen BCVA were converted to logarithm of the minimum angle of resolution (logMAR) BCVA
Measured: 12 month
Complications
Such as elevated intraocular pressure,retinal tear,rhegmatogenous retinal detachment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startJan 2013
- Primary completionApr 2014 (estimated)
- Study completionMay 2014 (estimated)
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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yifan Feng
- Sponsor type
- University, hospital or other
- Collaborators
- Wenzhou Medical University
- Responsible party
- Sponsor-investigator, Yifan Feng, Wenzhou Medical University
- Investigators
- Yifan Feng, MD, Principal investigator, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687829
- Sponsor's protocol ID
- F20120913
- Status last verified
- Feb 2014
- First submitted
- 13 Sep 2012
- Last updated
- 13 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Hole Surgery With and Without Internal Limiting Membrane Peeling：A Systematic Review and Meta-analysis
- ClinicalTrials.gov ID
- NCT01687829
- Acronym / sponsor ID
- F20120913
- Conditions
- Macular Holes
- Keywords
- Macular Holes, Internal limiting membrane, peeling, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yifan FengUniversity, hospital or other
- Collaborators
- Wenzhou Medical University
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 19 Sep 2012 (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.
Since Kelly and Wendel first reported successful closure of idiopathic macular holes (MH) by vitrectomy in 1991, many surgical modifications have been made to improve the anatomical and visual outcomes of this surgery. Recently, internal limiting membrane (ILM) peeling has become used widely as an adjunctive procedure during MH surgery because the removal of ILM is thought to reduce the tangential traction on the macula, a major factor in the pathogenesis of idiopathic macular holes. However, the role of ILM peeling in macular hole surgery is not yet well defined. To the best of our knowledge, there is no meta-analysis on comparison of the efficacy of ILM peeling and suture for MH surgery. This study reviewed the published literature comparing surgical results with and without ILM peeling and and performed a meta-analysis to determine whether there is any benefit or detriment anatomically and/or visually.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ILM-on group | – | –patients were scheduled to undergo macular hole surgery without internal limiting membrane (ILM) peeling |
| ILM-off group | – | –patients were scheduled to undergo macular hole surgery with internal limiting membrane (ILM) peeling |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients were scheduled to undergo macular hole surgery and randomized to with and without internal limiting membrane (ILM) peeling
Key inclusion criteria (1 listed)
- Eligible participants are those with idiopathic FTMH in stages 2-3, of less or equal than 18 months duration (based on symptoms reported by the patient) and with a visual acuity equal to or worse than 20/40 in the study eye.
Key exclusion criteria (2 listed)
- Patients with idiopathic FTMH stages 2-3 but longer than 18 months duration or with other causes of decreased vision (e.g. corneal scarring, age-related macular degeneration, diabetic retinopathy, glaucoma if central and/or paracentral absolute visual field defects are present) and
- Those with FTMH related to high myopia (> 6 dioptres) or trauma will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anatomic Success rate
Time frame: 12 months
Anatomic success defined as a closed hole without a visible edge or a flat hole without a rim of subretinal fluid.
Functional Success Rate
Time frame: 12 month
Functional Success defined as an improvement of 2 or more Snellen BCVA.
2 secondary outcomes
Best-corrected visual acuity
Time frame: 12 month
Complications
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
Related trials for Macular Holes
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Recruiting
Autologous Tenon's Capsule Graft for Refractory Macular Holes
Macular Hole Surgery
Active, not recruiting
Outcomes of Macular Hole Surgery With Inverted Flap With vs Without Post op Posturing With SF6 in Macular Hole More Than 400 Micrometres
Macular Hole
Recruiting
Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes
Macular Holes
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.
Yifan Feng, MD principal investigator
Wenzhou Medical University
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 Yifan Feng at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Feb 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomic Success rate (time frame: 12 months). The study lists 2 primary outcomes in all. 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 13 Feb 2014.