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

NCT03433547 — Not applicable, Completed, 50 participants, Sun Yat-sen University

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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

Registry	NCT03433547
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	50 (Actual)
Sponsor	Sun Yat-sen University (Other)
Conditions	Macular Holes, High Myopia, Macular Detachment
Interventions	Buckle, Vitrectomy, Limbal paracentesis, Gas injection, Peeling internal limiting membrane, Gas tamponade (Procedure, other)
Dates	start 2018-01-30, primary completion 2018-07-20, completion 2018-08-20, first posted 2018-02-14, last updated 2018-10-09
Locations	1 site in China

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Buckle	Experimental	Procedure: Buckle; Other: Limbal paracentesis; Other: Gas injection	Macular buckling, Limbal paracentesis, and intraocular gas injection.
Vitrectomy	Active comparator	Procedure: Vitrectomy; Other: Peeling internal limiting membrane; Other: Gas tamponade	Vitrectomy, peeling internal limiting membrane, and gas tamponade.

Buckle (Procedure), also known as Implantation of a device of macular buckling: Surgical procedures of macular buckling
Vitrectomy (Procedure): Surgical procedures of small gauge vitrectomy
Limbal paracentesis (Other): Drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis
Gas injection (Other): Inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous cavity through pars plana.
Peeling internal limiting membrane (Other): Peeling internal limiting membrane with forceps
Gas tamponade (Other): Filling the vitreous cavity with gas (C3F8, 14%)

+Outcome measures

Primary outcomes

Retinal re-attachment rate [1 month]: Successful rate of reattachment of macular retina after surgery

Secondary outcomes

Macular hole status [3 month]: Closure rate of macular hole after surgery on optical coherence tomography
Post-operative best corrected visual acuity [3 month]: Best corrected visual acuity of the eyes after surgery

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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:

* 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

+Locations (1)

Facility	City	Country	Status
Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou, Guangdong	China

+Publications

Results publication: 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. PMID 33397654
Results publication: 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. PMID 32408387

+Investigators

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

My Notes

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