NCT00485199

Brief Summary

To undertake a prospective randomized clinical study for treating retinal detachment due to myopic macular holes, utilizing pneumatic retinopexy versus pars plana vitrectomy with gas tamponade.To determine the efficiency of pneumatic retinopexy with C3F8 in the treatment of retinal detachment due to myopic macular hole.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
231

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable

Geographic Reach
1 country

14 active sites

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

January 1, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2007

Completed
Last Updated

June 12, 2007

Status Verified

June 1, 2007

First QC Date

June 11, 2007

Last Update Submit

June 11, 2007

Conditions

Retinal Detachment

Keywords

Pneumatic Retinopexyvitrectomyretinal detachmentmacular holetreatmentmulti-centerRetinal Detachment due to Myopic Macular hole

Outcome Measures

Primary Outcomes (1)

  • BCVA improvement,anatomic success

    1,3,6,9, and 12 months after treatment

Secondary Outcomes (2)

  • costs of treatment

    right after the treatment

  • complication

    1,3,6,9, 12 months after treatment

Interventions

Pneumatic RetinopexyPROCEDURE
Vitrectomy with GasPROCEDURE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • retinal detachment due to myopic macular hole.
  • The ability to give informed consent and to return for follow-up visit for 12 months

You may not qualify if:

  • retinal detachment with macular hole and peripheral hole/tear
  • retinal detachment with severe proliferative vitreoretinopathy
  • retinal detachment with choroidal detachment or rupture
  • traction retinal detachment due to retinal vascular disease
  • had vitrectomy in the past
  • macular hole without retinal detachment
  • foveal schiesis without retinal detachment
  • secondary macular hole with retinal detachment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Department of ophthalmology of People Hospital, Peking University

Beijing, Beijing Municipality, 100044, China

Location

Department of ophthalmology of Beijing Hospital

Beijing, Beijing Municipality, China

Location

Department of ophthalmology of Beijing Tong Ren Hospital

Beijing, Beijing Municipality, China

Location

Department of ophthalmology of China PLA General Hospital

Beijing, Beijing Municipality, China

Location

Peking Eye Center of the third affiliated Hospital of Peking University

Beijing, Beijing Municipality, China

Location

Zhong Shan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Department of ophthalmology of The Second affiliated Xiang Ya Hospital, Central South University

Changsha, Hunan, China

Location

Department of ophthalmology of The First affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Department of ophthalmology of The First affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Shandong Eye Institute

Qingdao, Shandong, China

Location

Department of ophthalmology of EENT Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Location

Department of ophthalmology of The First affiliated People Hospital of Shang Hai Jiao Tong University

Shanghai, Shanghai Municipality, China

Location

Department of ophthalmology of West China Hospital, Sichuan University

Chengdu, Sichuan, China

Location

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

Location

Related Publications (1)

  • 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 DetachmentRetinal Perforations

Interventions

VitrectomyGases

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, OperativeInorganic Chemicals

Study Officials

  • Xiaoxin Li, professor

    Peking University

    STUDY CHAIR

  • Jialiang Zhao, professor

    Eye Institute of Peking Union Hospital, Peking Union Medical College

    PRINCIPAL INVESTIGATOR

  • Wenji Wang, professor

    Department of ophthalmology of Eye Ear Nose Throat Hospital, Fudan University, Shanghai

    PRINCIPAL INVESTIGATOR

  • Shibo Tang, professor

    Zhong Shan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2007

First Posted

June 12, 2007

Study Start

January 1, 2005

Study Completion

December 1, 2006

Last Updated

June 12, 2007

Record last verified: 2007-06

Locations

CN(14)