NCT03433547

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	Buckle	Surgical procedures of macular buckling
PROCEDURE	Vitrectomy	Surgical procedures of small gauge vitrectomy
OTHER	Limbal paracentesis	Drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis
OTHER	Gas injection	Inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous cavity through pars plana.
OTHER	Peeling internal limiting membrane	Peeling internal limiting membrane with forceps
OTHER	Gas tamponade	Filling the vitreous cavity with gas (C3F8, 14%)

Timeline

• Start date: 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 across 1 country: China