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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

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.

02

Conditions studied

  • Macular Holes
  • High Myopia
  • Macular Detachment

Keywords

  • macular buckling
  • full-thickness macular hole
  • macular detachment
  • internal limiting membrane peeling
  • high myopia
03

Who can participate

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

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
04

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%)

05

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

06

Study locations

1 site
  • Zhongshan Ophthalmic Center, Sun Yat-sen University
    Guangzhou, Guangdong 510060, China
07

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

08

Registry details

Key details

Study ID
NCT03433547
Lead sponsor
Sun Yat-sen University
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 ↗

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