Partial Posterior Hyaloidectomy in Macular Surgery
|ClinicalTrials.gov Identifier: NCT01454466|
Recruitment Status : Completed
First Posted : October 19, 2011
Last Update Posted : October 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Retinal Break Retinal Detachment||Procedure: Partial posterior hyaloidectomy (a modified procedure of vitrectomy)||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||November 2009|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Procedure: Partial posterior hyaloidectomy (a modified procedure of vitrectomy)
- incidence of intraoperative and postoperative retinal break related to surgery [ Time Frame: postoperative 3 to 6 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454466
|Study Chair:||Se Woong Kang, M.D.||Samsung Medical Center|
|Principal Investigator:||Jae Hui Kim, M.D.||Samsung Medical Center|