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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT03433547
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
6.6
Actual Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Buckle
  • Procedure: Vitrectomy
  • Other: Limbal paracentesis
  • Other: Gas injection
  • Other: Peeling internal limiting membrane
  • Other: Gas tamponade
 N/A

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.

Study Design

Study Type:
Interventional
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 :
Jan 30, 2018
Actual Primary Completion Date :
Jul 20, 2018
Actual Study Completion Date :
Aug 20, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Buckle

Macular buckling, Limbal paracentesis, and intraocular gas injection.

Procedure: Buckle
Surgical procedures of macular buckling
Other Names:
  • 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%)

    Outcome Measures

    Primary Outcome Measures

    1. Retinal re-attachment rate [1 month]

      Successful rate of reattachment of macular retina after surgery

    Secondary Outcome Measures

    1. Macular hole status [3 month]

      Closure rate of macular hole after surgery on optical coherence tomography

    2. Post-operative best corrected visual acuity [3 month]

      Best corrected visual acuity of the eyes after surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    • Principal Investigator: Lin Lu, MD，PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lin Lu, professor, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT03433547
    Other Study ID Numbers:
    • 2013meky013-3
    First Posted:
    Feb 14, 2018
    Last Update Posted:
    Oct 9, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lin Lu, professor, Sun Yat-sen University
    macular buckling
    full-thickness macular hole
    macular detachment
    internal limiting membrane peeling
    high myopia
    Additional relevant MeSH terms:
    Myopia
    Retinal Perforations
    Dissociative Disorders

    Study Results

    No Results Posted as of Oct 9, 2018