NCT03433547

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

January 23, 2018

Last Update Submit

October 8, 2018

Conditions

Macular HolesHigh MyopiaMacular Detachment

Keywords

macular bucklingfull-thickness macular holemacular detachmentinternal limiting membrane peelinghigh myopia

Outcome Measures

Primary Outcomes (1)

  • Retinal re-attachment rate

    Successful rate of reattachment of macular retina after surgery

    1 month

Secondary Outcomes (2)

  • Macular hole status

    3 month

  • Post-operative best corrected visual acuity

    3 month

Study Arms (2)

Buckle

EXPERIMENTAL

Macular buckling, Limbal paracentesis, and intraocular gas injection.

Procedure: BuckleOther: Limbal paracentesisOther: Gas injection

Vitrectomy

ACTIVE COMPARATOR

Vitrectomy, peeling internal limiting membrane, and gas tamponade.

Procedure: VitrectomyOther: Peeling internal limiting membraneOther: Gas tamponade

Interventions

BucklePROCEDURE

Surgical procedures of macular buckling

Also known as: Implantation of a device of macular buckling
Buckle
VitrectomyPROCEDURE

Surgical procedures of small gauge vitrectomy

Vitrectomy
Limbal paracentesisOTHER

Drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis

Buckle
Gas injectionOTHER

Inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous cavity through pars plana.

Buckle
Peeling internal limiting membraneOTHER

Peeling internal limiting membrane with forceps

Vitrectomy
Gas tamponadeOTHER

Filling the vitreous cavity with gas (C3F8, 14%)

Vitrectomy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (2)

  • Zhao X, Li Y, Ma W, Lian P, Yu X, Chen S, Huang X, Liu B, Lu L. Macular buckling versus vitrectomy on macular hole associated macular detachment in eyes with high myopia: a randomised trial. Br J Ophthalmol. 2022 Apr;106(4):582-586. doi: 10.1136/bjophthalmol-2020-317800. Epub 2021 Jan 4.

    PMID: 33397654DERIVED

  • Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.

    PMID: 32408387DERIVED

MeSH Terms

Conditions

Retinal Perforations

Interventions

VitrectomyGases

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, OperativeInorganic Chemicals

Study Officials

  • Lin Lu, MD，PhD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 23, 2018

First Posted

February 14, 2018

Study Start

January 30, 2018

Primary Completion

July 20, 2018

Study Completion

August 20, 2018

Last Updated

October 9, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)