Macular HolesNCT01229657
Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes
An observational study of Macular Holes, run by Sun Yat-sen University at 1 site in China.
Trial summary
To evaluate the anatomic and visual outcomes in patients with initially closed macular holes after vitreoretinal surgery and with one to seven years of follow-up. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Macular Holes
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- Mar 2010to May 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: Patients with initially closed macular holes after vitreoretinal surgery and with one to seven years of follow-up
Who may be able to join
- successful closure of a macular hole after initial vitreoretinal surgery
- a follow-up of at least one year
Who cannot join
- post-traumatic holes,
- myopic macular holes,
- macular holes associated with a rhegmatogenous retinal detachment,
- eyes with silicone oil tamponade.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Study of the Anatomic and Visual Outcomes in Patients With Initially Closed Macular Holes After Vitreoretinal Surgery
To evaluate the anatomic and visual outcomes in patients with initially closed macular holes after vitreoretinal surgery and with one to seven years of follow-up.
Read the detailed description
In recent years, peeling of the internal limiting membrane (ILM) has been used as a supplementary treatment to reducing the tangential tractional forces and inducing hole closure in macular hole surgery, and thus the anatomic success rate has increased to over 90%. However, despite these high rates of surgical success, the reopening of initially closed macular holes has also been observed from the first month to several years following surgery. Because about 45% to 95% of phakic patients frequently develop a progressive nuclear sclerosis cataract after macular hole surgery and require combined or subsequent cataract extraction to improve visual acuity, cataract extraction has become a potential factor in causing macular hole reopening, although this is still under debate. The purpose of this study is to describe the long-term anatomic and visual outcomes in patients who had initial anatomic success with macular hole surgery and who had postoperative follow-up of one or more years. All patient's charts were reviewed for age, macular hole stage (using the Gass classification), macular hole duration, epiretinal membrane of macula presence, ILM peeling, preoperative and postoperative visual acuity, rate of macular hole reopening, cataract extraction, and length of follow-up after vitrectomy.
- Conditions
- Macular Holes
- Keywords
- Reopening of macular hole;, Visual acuity;, Phacoemulsification cataract surgery;, Vitrectomy
- Medical subject headings
- Retinal Perforations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2010
- Study completionMay 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.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Shaochong Zhang, MD, Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229657
- Sponsor's protocol ID
- SunYat-senU
- Other IDs
- 2008B030301306, 2007B031302007
- Status last verified
- Oct 2010
- First submitted
- 27 Oct 2010
- Last updated
- 28 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Anatomic and Visual Outcomes in Patients With Initially Closed Macular Holes After Vitreoretinal Surgery
- ClinicalTrials.gov ID
- NCT01229657
- Acronym / sponsor ID
- SunYat-senU
- Conditions
- Macular Holes
- Keywords
- Reopening of macular hole;, Visual acuity;, Phacoemulsification cataract surgery;, Vitrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 28 Oct 2010 (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.
To evaluate the anatomic and visual outcomes in patients with initially closed macular holes after vitreoretinal surgery and with one to seven years of follow-up.
Detailed description
In recent years, peeling of the internal limiting membrane (ILM) has been used as a supplementary treatment to reducing the tangential tractional forces and inducing hole closure in macular hole surgery, and thus the anatomic success rate has increased to over 90%. However, despite these high rates of surgical success, the reopening of initially closed macular holes has also been observed from the first month to several years following surgery. Because about 45% to 95% of phakic patients frequently develop a progressive nuclear sclerosis cataract after macular hole surgery and require combined or subsequent cataract extraction to improve visual acuity, cataract extraction has become a potential factor in causing macular hole reopening, although this is still under debate. The purpose of this study is to describe the long-term anatomic and visual outcomes in patients who had initial anatomic success with macular hole surgery and who had postoperative follow-up of one or more years. All patient's charts were reviewed for age, macular hole stage (using the Gass classification), macular hole duration, epiretinal membrane of macula presence, ILM peeling, preoperative and postoperative visual acuity, rate of macular hole reopening, cataract extraction, and length of follow-up after vitrectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with initially closed macular holes after vitreoretinal surgery and with one to seven years of follow-up
Key inclusion criteria (2 listed)
- successful closure of a macular hole after initial vitreoretinal surgery
- a follow-up of at least one year
Key exclusion criteria (4 listed)
- post-traumatic holes,
- myopic macular holes,
- macular holes associated with a rhegmatogenous retinal detachment,
- eyes with silicone oil tamponade.
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
Not reported in the source record.
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 28 Oct 2010.
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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.
Shaochong Zhang, MD study chair
Zhongshan Ophthalmic Center, Sun Yat-sen 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 Sun Yat-sen University 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 2 inclusion and 4 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 28 Oct 2010. 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?
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.
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 28 Oct 2010.