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OpenTrials
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NCT Number: NCT03433547

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

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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Key information

Conditions

Macular Holes Eye Diseases High Myopia Macular Detachment Retinal Diseases Retinal Perforations

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buckle

Procedure

Surgical procedures of macular buckling

Other names: Implantation of a device 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%)

Primary outcomes

  1. Retinal re-attachment rate

    Time frame: 1 month

    Successful rate of reattachment of macular retina after surgery

Secondary outcomes

  1. Macular hole status

    Time frame: 3 month

    Closure rate of macular hole after surgery on optical coherence tomography

  2. Post-operative best corrected visual acuity

    Time frame: 3 month

    Best corrected visual acuity of the eyes after surgery

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 14, 2018
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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