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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03433547
Recruitment Status : Completed
First Posted : February 14, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Lin Lu, Sun Yat-sen University

Brief 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.

Condition or disease Intervention/treatment Phase
Macular Holes High Myopia Macular Detachment Procedure: Buckle Procedure: Vitrectomy Other: Limbal paracentesis Other: Gas injection Other: Peeling internal limiting membrane Other: Gas tamponade Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : August 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Buckle
Macular buckling, Limbal paracentesis, and intraocular gas injection.
Procedure: Buckle
Surgical procedures of macular buckling
Other Name: Implantation of a device of macular buckling

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.

Active Comparator: Vitrectomy
Vitrectomy, peeling internal limiting membrane, and gas tamponade.
Procedure: Vitrectomy
Surgical procedures of small gauge vitrectomy

Other: Peeling internal limiting membrane
Peeling internal limiting membrane with forceps

Other: Gas tamponade
Filling the vitreous cavity with gas (C3F8, 14%)




Primary Outcome Measures :
  1. Retinal re-attachment rate [ Time Frame: 1 month ]
    Successful rate of reattachment of macular retina after surgery


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433547


Locations
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China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Lin Lu, MD,PhD Zhongshan Ophthalmic Center, Sun Yat-sen University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lin Lu, professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03433547    
Other Study ID Numbers: 2013meky013-3
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lin Lu, Sun Yat-sen University:
macular buckling
full-thickness macular hole
macular detachment
internal limiting membrane peeling
high myopia
Additional relevant MeSH terms:
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Myopia
Retinal Perforations
Dissociative Disorders
Refractive Errors
Eye Diseases
Mental Disorders
Retinal Diseases