Partial Posterior Hyaloidectomy in Macular Surgery

Retinal Detachment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454466
• Other study ID #: 2011-05-011
• Status: Completed
• Phase: Phase 1
• First received: October 17, 2011
• Last updated: October 18, 2011
• Start date: November 2009
• Est. completion date: July 2011

Study information

• Verified date: October 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• history of previous intraocular surgery

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Retinal Break
• Retinal Detachment
• Retinal Perforations

Intervention

Procedure:
• Partial posterior hyaloidectomy (a modified procedure of vitrectomy)
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes