Macular HolesNCT03433547
Effects of Macular Buckle Versus Vitrectomy on Macular Hole and Macular Detachment in Highly Myopic Eyes
A study testing Buckle, Vitrectomy and Limbal paracentesis in people with Macular Holes and High Myopia, run by Sun Yat-sen University at 1 site in China.
Trial summary
Full-thickness macular Hole associated with macular detachment is a one of the maculopathies of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling versus vitrectomy in a cohort of highly myopic eyes with this situation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Macular Holes, High Myopia, Macular Detachment
- What is being tested?
- Buckle, Vitrectomy and Limbal paracentesis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2018to 20 Aug 2018
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter
- full-thickness macular hole
- macular retinal detachment
- evidence of posterior staphyloma on clinical examination
Who cannot join
- macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)
- a history of vitrectomy or scleral buckling
- intraocular active hemorrhage or inflammation
- any media opacity which precluded imaging or clinical evaluation of the macula
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: A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy on Full-thickness Macular Hole and Concurrent Macular Detachment in Eyes With Highly Myopia
Full-thickness macular Hole associated with macular detachment is a one of the maculopathies of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling versus vitrectomy in a cohort of highly myopic eyes with this situation.
Read the detailed description
A randomized, open label, single center study comparing the efficacy of macular muckle + gas injection versus internal limiting membrane peeling + gas tamponade on full-thickness macular hole associated with macular detachment in eyes with high myopia.
- Conditions
- Macular Holes, High Myopia, Macular Detachment
- Being tested
- Buckle, Vitrectomy, Limbal paracentesis, Gas injection, Peeling internal limiting membrane
- Keywords
- macular buckling, full-thickness macular hole, macular detachment, internal limiting membrane peeling, high myopia
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuckleProcedure or surgery
Also called Implantation of a device of macular buckling
Surgical procedures of macular buckling
VitrectomyProcedure or surgery
Surgical procedures of small gauge vitrectomy
Limbal paracentesisOther
Drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis
Gas injectionOther
Inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous cavity through pars plana.
Peeling internal limiting membraneOther
Peeling internal limiting membrane with forceps
Gas tamponadeOther
Filling the vitreous cavity with gas (C3F8, 14%)
| Study group | Role | What they receive |
|---|---|---|
| Buckle | Experimental | Macular buckling, Limbal paracentesis, and intraocular gas injection. Receives: Procedure: Buckle; Other: Limbal paracentesis; Other: Gas injection |
| Vitrectomy | Active comparator | Vitrectomy, peeling internal limiting membrane, and gas tamponade. Receives: Procedure: Vitrectomy; Other: Peeling internal limiting membrane; Other: Gas tamponade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal re-attachment rate
Successful rate of reattachment of macular retina after surgery
Measured: 1 month
Secondary outcomes (2)
Macular hole status
Closure rate of macular hole after surgery on optical coherence tomography
Measured: 3 month
Post-operative best corrected visual acuity
Best corrected visual acuity of the eyes after surgery
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start30 Jan 2018
- Primary completion20 Jul 2018
- Study completion20 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Lu, Sun Yat-sen University
- Investigators
- Lin Lu, MD，PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433547
- Sponsor's protocol ID
- 2013meky013-3
- Status last verified
- Oct 2018
- First submitted
- 23 Jan 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao X, Li Y, Ma W, Lian P, Yu X, Chen S, Huang X, Liu B, Lu L. Macular buckling versus vitrectomy on macular hole associated macular detachment in eyes with high myopia: a randomised trial. Br J Ophthalmol. 2022 Apr;106(4):582-586. doi: 10.1136/bjophthalmol-2020-317800. Epub 2021 Jan 4.
PubMed 33397654Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.
PubMed 32408387
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy on Full-thickness Macular Hole and Concurrent Macular Detachment in Eyes With Highly Myopia
- ClinicalTrials.gov ID
- NCT03433547
- Acronym / sponsor ID
- 2013meky013-3
- Conditions
- Macular Holes, High Myopia, Macular Detachment
- Keywords
- macular buckling, full-thickness macular hole, macular detachment, internal limiting membrane peeling, high myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 14 Feb 2018 (actual)
- 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.
Full-thickness macular Hole associated with macular detachment is a one of the maculopathies of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling versus vitrectomy in a cohort of highly myopic eyes with this situation.
Detailed description
A randomized, open label, single center study comparing the efficacy of macular muckle + gas injection versus internal limiting membrane peeling + gas tamponade on full-thickness macular hole associated with macular detachment in eyes with high myopia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buckle | Experimental | Procedure: Buckle, Other: Limbal paracentesis, Other: Gas injectionMacular buckling, Limbal paracentesis, and intraocular gas injection. |
| Vitrectomy | Active comparator | Procedure: Vitrectomy, Other: Peeling internal limiting membrane, Other: Gas tamponadeVitrectomy, peeling internal limiting membrane, and gas tamponade. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter
- full-thickness macular hole
- macular retinal detachment
- evidence of posterior staphyloma on clinical examination
Key exclusion criteria (4 listed)
- macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)
- a history of vitrectomy or scleral buckling
- intraocular active hemorrhage or inflammation
- any media opacity which precluded imaging or clinical evaluation of the macula
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 |
|---|---|---|
| BuckleAlso: Implantation of a device of macular bucklingSurgical procedures of macular buckling | Procedure or surgery | Buckle |
| VitrectomySurgical procedures of small gauge vitrectomy | Procedure or surgery | Vitrectomy |
| Limbal paracentesisDrainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis | Other | Buckle |
| Gas injectionInject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous cavity through pars plana. | Other | Buckle |
| Peeling internal limiting membranePeeling internal limiting membrane with forceps | Other | Vitrectomy |
| Gas tamponadeFilling the vitreous cavity with gas (C3F8, 14%) | Other | Vitrectomy |
Primary outcome
Retinal re-attachment rate
Time frame: 1 month
Successful rate of reattachment of macular retina after surgery
2 secondary outcomes
Macular hole status
Time frame: 3 month
Post-operative best corrected visual acuity
Time frame: 3 month
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 9 Oct 2018.
- Derived from this study: PubMed 33397654Zhao X, Li Y, Ma W, Lian P, Yu X, Chen S, Huang X, Liu B, Lu L. Macular buckling versus vitrectomy on macular hole associated macular detachment in eyes with high myopia: a randomised trial. Br J Ophthalmol. 2022 Apr;106(4):582-586. doi: 10.1136/bjophthalmol-2020-317800. Epub 2021 Jan 4.
- Derived from this study: PubMed 32408387Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.
- 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.
Lin Lu, MD，PhD principal investigator
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?
A study testing Buckle, Vitrectomy and Limbal paracentesis in people with Macular Holes and High Myopia, 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 4 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 9 Oct 2018. 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.
What does the primary outcome measure?
Retinal re-attachment rate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03433547, which also lists 2 linked publications.
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 9 Oct 2018.