NCT01454466

Brief Summary

To evaluate the effect of partial posterior hyaloidectomy on preventing iatrogenic retinal breaks related to induction of a posterior vitreous detachment

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2009

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
Last Updated

October 19, 2011

Status Verified

October 1, 2011

Enrollment Period

1.7 years

First QC Date

October 17, 2011

Last Update Submit

October 18, 2011

Conditions

Retinal BreakRetinal Detachment

Keywords

preventionretinal breakvitrectomypartial posterior hyaloidectomy

Outcome Measures

Primary Outcomes (1)

  • incidence of intraoperative and postoperative retinal break related to surgery

    The eyes that completed a follow-up of at least 3 months were included in the result analysis. The incidence of retinal breaks related to the surgery was measured.

    postoperative 3 to 6 months

Interventions

Partial posterior hyaloidectomy (a modified procedure of vitrectomy)PROCEDURE

The core vitrectomy entails more extensive removal of vitreous gel, in contrast to the conventional core vitrectomy. IPVD was conducted by engaging the attached posterior cortical vitreous with a 23-gauge needle with angulated tip in the area adjacent to the optic disc followed by gently moving the tip to approximately 3 disc diameters away from the margin of the optic disc. After then, slightly elevating the tip in a posteroanterior direction with slowly proceeding it to the extent that we planned. With IPVD, the surgeon was able to visualize a floating Weiss ring in all of the cases. Active suction to initiate IPVD was not used in any of the cases. In the temporal direction, the extension of a PVD was restricted to approximately 2 disc diameters distance beyond the margin of temporal major vascular arcade

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cases of idiopathic ERM or idiopathic MH without evidence of PVD preoperatively

You may not qualify if:

  • history of previous intraocular surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Retinal PerforationsRetinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Se Woong Kang, M.D.

    Samsung Medical Center

    STUDY CHAIR

  • Jae Hui Kim, M.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2011

First Posted

October 19, 2011

Study Start

November 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 19, 2011

Record last verified: 2011-10