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

Macular Holes Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433547
• Other study ID #: 2013meky013-3
• Status: Completed
• Phase: N/A
• Start date: January 30, 2018
• Est. completion date: August 20, 2018

Study information

• Verified date: October 2018
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 20, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dissociative Disorders
• High Myopia
• Macular Detachment
• Macular Holes
• Myopia
• Retinal Perforations

Intervention

Procedure:
• Buckle
Surgical procedures of macular buckling
• Vitrectomy
Surgical procedures of small gauge vitrectomy

Other:
• Limbal paracentesis
Drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis
• Gas injection
Inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous cavity through pars plana.
• Peeling internal limiting membrane
Peeling internal limiting membrane with forceps
• Gas tamponade
Filling the vitreous cavity with gas (C3F8, 14%)

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal re-attachment rate	Successful rate of reattachment of macular retina after surgery	1 month
Secondary	Macular hole status	Closure rate of macular hole after surgery on optical coherence tomography	3 month
Secondary	Post-operative best corrected visual acuity	Best corrected visual acuity of the eyes after surgery	3 month