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CompletedNCT03433547Updated Oct 9, 2018

Effects of Macular Buckle Versus Vitrectomy on Macular Hole and Macular Detachment in Highly Myopic Eyes

An interventional study of Buckle and Vitrectomy in Macular Holes, High Myopia and Macular Detachment, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-10-09.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 17 studies in Retinal Perforations with a site in China — 4 open to participants now, 6 under way, none of them phase 3. Retinal Perforations · China.

Enrollment
8th of 13
50 · median 52
Started
2018
the only one that year
No phase
12 of 17
4 open now
Registered
7th of 17
by date
Lead sponsor
2 of 17
Sun Yat-sen University

Among the 17 studies in Retinal Perforations with a site in China, this one is the 8th largest by enrollment of the 13 interventional ones, is the only one that started in 2018, is one of 12 with no phase, and was the 7th registered.

By phase

17 studies; the count open now beside each. This study's row is marked.

No phasethis study12 · 4 open
Observational4 · 0 open
Phase 11 · 0 open

By the year they started

First in 2005; this study’s year is marked. 1 started in 2018.

Size and results

Median enrollment 52 across the 13 interventional studies, 240 across the 4 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 17 studies in Retinal Perforations with a site in China, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Macular Holes
  • High Myopia
  • Macular Detachment

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Keywords

  • macular buckling
  • full-thickness macular hole
  • macular detachment
  • internal limiting membrane peeling
  • high myopia
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Buckle

    Macular buckling, Limbal paracentesis, and intraocular gas injection.

    Procedure: Buckle · Other: Limbal paracentesis · Other: Gas injection

  • Active comparator
    Vitrectomy

    Vitrectomy, peeling internal limiting membrane, and gas tamponade.

    Procedure: Vitrectomy · Other: Peeling internal limiting membrane · Other: Gas tamponade

Interventions

  • ProcedureBuckle

    Surgical procedures of macular buckling

    Also known as: Implantation of a device of macular buckling

  • ProcedureVitrectomy

    Surgical procedures of small gauge vitrectomy

  • OtherLimbal paracentesis

    Drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis

  • OtherGas injection

    Inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous cavity through pars plana.

  • OtherPeeling internal limiting membrane

    Peeling internal limiting membrane with forceps

  • OtherGas tamponade

    Filling the vitreous cavity with gas (C3F8, 14%)

06

What researchers measure

Primary outcomes

  1. Retinal re-attachment rate

    Successful rate of reattachment of macular retina after surgery

    Time frame: 1 month

Secondary outcomes

  1. Macular hole status

    Closure rate of macular hole after surgery on optical coherence tomography

    Time frame: 3 month

  2. Post-operative best corrected visual acuity

    Best corrected visual acuity of the eyes after surgery

    Time frame: 3 month

07

Study locations

1 site
  • Zhongshan Ophthalmic Center, Sun Yat-sen University
    Guangzhou, Guangdong 510060, China
08

References and documents

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 33397654 ↗
  • Schwartz 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Jul 2018, 5 months.

Of 45 non-industry interventional studies with no phase under Retinal Perforations, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's 5 months is below that.

Counting every sponsor, half of 45 studies reached it within 28 months; a quarter within 12 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2018
First posted
Feb 14, 2018
StartActual
Jan 30, 2018
Primary completionActual
Jul 20, 2018
CompletionActual
Aug 20, 2018
Last update
Oct 9, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03433547
Responsible party
Lin Lu (professor, Sun Yat-sen University) — Principal investigator
First posted
Feb 14, 2018
Start date
Jan 30, 2018
Primary completion
Jul 20, 2018
Completion
Aug 20, 2018
Last update
Oct 9, 2018

Study contacts

Lin Lu, MD,PhD
principal investigator · Zhongshan Ophthalmic Center, Sun Yat-sen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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