Partial Posterior Hyaloidectomy in Macular Surgery

Partial Posterior Hyaloidectomy in Macular Surgery : A Modified Procedure of Vitrectomy to Prevent Retinal Break Related to Induction of a Posterior Vitreous Detachment

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

Study Overview

• Status: Completed
• Conditions: Retinal Detachment; Retinal Break
• Intervention / Treatment: Procedure: Partial posterior hyaloidectomy (a modified procedure of vitrectomy)

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• history of previous intraocular surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Study Chair: Se Woong Kang, M.D., Samsung Medical Center; Principal Investigator: Jae Hui Kim, M.D., Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: October 17, 2011
• First Submitted That Met QC Criteria: October 18, 2011
• First Posted (Estimate): October 19, 2011

Study Record Updates

• Last Update Posted (Estimate): October 19, 2011
• Last Update Submitted That Met QC Criteria: October 18, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: prevention; vitrectomy; retinal break; partial posterior hyaloidectomy
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations; Retinal Detachment
• Other Study ID Numbers: 2011-05-011