Partial Posterior Hyaloidectomy in Macular Surgery
Primary Purpose
Retinal Break, Retinal Detachment
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Partial posterior hyaloidectomy (a modified procedure of vitrectomy)
Sponsored by
About this trial
This is an interventional prevention trial for Retinal Break focused on measuring prevention, retinal break, vitrectomy, partial posterior hyaloidectomy
Eligibility Criteria
Inclusion Criteria:
- Cases of idiopathic ERM or idiopathic MH without evidence of PVD preoperatively
Exclusion Criteria:
- history of previous intraocular surgery
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01454466
First Posted
October 17, 2011
Last Updated
October 18, 2011
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01454466
Brief Title
Partial Posterior Hyaloidectomy in Macular Surgery
Official Title
Partial Posterior Hyaloidectomy in Macular Surgery : A Modified Procedure of Vitrectomy to Prevent Retinal Break Related to Induction of a Posterior Vitreous Detachment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the effect of partial posterior hyaloidectomy on preventing iatrogenic retinal breaks related to induction of a posterior vitreous detachment
Detailed Description
The induction of a posterior vitreous detachment (IPVD) during vitrectomy have been suggested as one of the etiologies of iatrogenic retinal break related to vitrectomy.The iatrogenic retinal breaks related to IPVD usually develop near or anterior to the equatorial region.
Thus, the investigators hypothesized that this complication could be prevented by restricting the extent of IPVD, and planned a modified procedure of vitrectomy in which the extent of IPVD and removal of vitreous cortex was restricted to about slightly beyond the margin of temporal major vascular arcade.
The investigators have termed this procedure, partial posterior hyaloidectomy. Unlike RRD or proliferative diabetic retinopathy, lesions are localized within the major vascular arcade in macular disorders so that macular disorders could be an eligible indication for this procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Break, Retinal Detachment
Keywords
prevention, retinal break, vitrectomy, partial posterior hyaloidectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Partial posterior hyaloidectomy (a modified procedure of vitrectomy)
Intervention Description
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
Primary Outcome Measure Information:
Title
incidence of intraoperative and postoperative retinal break related to surgery
Description
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.
Time Frame
postoperative 3 to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cases of idiopathic ERM or idiopathic MH without evidence of PVD preoperatively
Exclusion Criteria:
history of previous intraocular surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Se Woong Kang, M.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jae Hui Kim, M.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Partial Posterior Hyaloidectomy in Macular Surgery
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