Partial Posterior Hyaloidectomy in Macular Surgery
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Purpose
To evaluate the effect of partial posterior hyaloidectomy on preventing iatrogenic retinal breaks related to induction of a posterior vitreous detachment
| Condition | Intervention | Phase |
|---|---|---|
|
Retinal Break Retinal Detachment |
Procedure: Partial posterior hyaloidectomy (a modified procedure of vitrectomy) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
- incidence of intraoperative and postoperative retinal break related to surgery [ Time Frame: postoperative 3 to 6 months ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 50 |
| Study Start Date: | November 2009 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
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Procedure: Partial posterior hyaloidectomy (a modified procedure of vitrectomy)
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.
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Cases of idiopathic ERM or idiopathic MH without evidence of PVD preoperatively
Exclusion Criteria:
- history of previous intraocular surgery
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT01454466 History of Changes |
| Other Study ID Numbers: | 2011-05-011 |
| Study First Received: | October 17, 2011 |
| Last Updated: | October 18, 2011 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Samsung Medical Center:
|
prevention retinal break vitrectomy partial posterior hyaloidectomy |
Additional relevant MeSH terms:
|
Retinal Detachment Retinal Perforations Vitreous Detachment Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013