NCT00927628

Brief Summary

The purpose of this investigation was to determine the incidence and the factors that cause a reopening of a macular hole (MH) after a surgical closure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
831

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1990

Longer than P75 for all trials

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

Study Start

First participant enrolled

October 1, 1990

Completed
18.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
Last Updated

June 25, 2009

Status Verified

June 1, 2009

Enrollment Period

18.2 years

First QC Date

June 24, 2009

Last Update Submit

June 24, 2009

Conditions

Vitrectomy

Keywords

vitrectomymacular holeILM peeling

Outcome Measures

Primary Outcomes (1)

  • A complete clinical examination including BCVA, slit-lamp biomicroscopy with a contact lens, indirect ophthalmoscopy, and fundus photography were performed post surgery.

    Patients were examined preoperatively and postoperatively on day one, and at two weeks, and one, three, and six months. Thereafter, they were examined every three to six months.

Study Arms (1)

Vitrectomy

Patients underwent vitrectomy with or without internal limiting membrane (ILM) peeling for an idiopathic full-thickness macular hole. Simultaneous phacoemulsification with intraocular lens implantation was performed on all phakic patients who were \>40-years-of-age.

Procedure: Vitrectomy

Interventions

VitrectomyPROCEDURE

Patients underwent vitrectomy with or without internal limiting membrane (ILM) peeling for an idiopathic full-thickness macular holes. Simultaneous phacoemulsification with intraocular lens implantation was performed on all phakic patients who were \>40-years-of-age.

Vitrectomy

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eight hundred seventy-seven eyes of 831 patients with a mean age of 64.9 ± 8.0 years were studied.

You may qualify if:

  • patients who underwent vitrectomy with or without internal limiting membrane (ILM) peeling for an idiopathic full-thickness macular hole

You may not qualify if:

  • eyes with previous vitreous surgery, cystoid macular edema from any cause, and traumatically-induced MH were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shinjo Ophthalmologic Institute

Miyazaki, Miyazaki, 880-0035, Japan

Location

Related Publications (6)

  • Duker JS, Wendel R, Patel AC, Puliafito CA. Late re-opening of macular holes after initially successful treatment with vitreous surgery. Ophthalmology. 1994 Aug;101(8):1373-8. doi: 10.1016/s0161-6420(13)31174-9.

    PMID: 8058282BACKGROUND

  • Kokame GT. Recurrence of macular holes. Ophthalmology. 1995 Feb;102(2):172-3. doi: 10.1016/s0161-6420(95)31042-1. No abstract available.

    PMID: 7862400BACKGROUND

  • Kumagai K, Furukawa M, Ogino N, Uemura A, Demizu S, Larson E. Vitreous surgery with and without internal limiting membrane peeling for macular hole repair. Retina. 2004 Oct;24(5):721-7. doi: 10.1097/00006982-200410000-00006.

    PMID: 15492625BACKGROUND

  • Gross JG. Late reopening and spontaneous closure of previously repaired macular holes. Am J Ophthalmol. 2005 Sep;140(3):556-8. doi: 10.1016/j.ajo.2005.03.044.

    PMID: 16139019BACKGROUND

  • Kumagai K, Furukawa M, Ogino N, Larson E, Uemura A. Long-term outcomes of macular hole surgery with triamcinolone acetonide-assisted internal limiting membrane peeling. Retina. 2007 Nov-Dec;27(9):1249-54. doi: 10.1097/IAE.0b013e3180ed45cc.

    PMID: 18046233BACKGROUND

  • Kumagai K, Ogino N, Furukawa M, Larson E, Uemura A. Surgical outcomes for patients who develop macular holes after pars plana vitrectomy. Am J Ophthalmol. 2008 Jun;145(6):1077-80. doi: 10.1016/j.ajo.2008.01.030. Epub 2008 Apr 18.

    PMID: 18378210BACKGROUND

MeSH Terms

Conditions

Retinal Perforations

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Kazuyuki Kumagai, MD

    Shinjo Ophthalmologic Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 24, 2009

First Posted

June 25, 2009

Study Start

October 1, 1990

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 25, 2009

Record last verified: 2009-06

Locations

JP(1)