Clinicopathologic Findings for Macular Disease
this study is to analyze and compare the ultrastructure of the retinal and vitreous plane of the epiretinal membrane and internal limiting membrane removed during macular surgery and to evaluate relation between the ultrastructure of the epiretinal membrane and internal limiting membrane and surgical outcomes.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Clinicopathologic Findings for Macular Disease|
- spectral domain optical coherence tomography [ Time Frame: baseline, 1week, 1month, 3 month ] [ Designated as safety issue: Yes ]The central 1mm subfield thickness the average macular thickness the inner nuclear layer thickness outer nuclear layer thickness outer plexiform layer thickness photoreceptor integrity ILM map RPE map
- best corrected visual acuity [ Time Frame: baseline, 1 month, 3 months ] [ Designated as safety issue: Yes ]logMAR
- electron microscopy finding of internal limiting membrane [ Time Frame: during operation ] [ Designated as safety issue: Yes ]
- visual field [ Time Frame: baseline, postoperative 1 months, 3 months ] [ Designated as safety issue: Yes ]humpley visual field
- preferential hyperacuity perimeter [ Time Frame: baseline, postoperative 1 months, 3 months ] [ Designated as safety issue: Yes ]ForeseePHP 2.05; Notal Vision, Tel Aviv, Israel
|Study Start Date:||May 2009|
|Study Completion Date:||June 2010|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Procedure: vitrectomy for macular disease
three-port pars plana vitrectomy was performed in each case using a vitreous cutter surrounded by a coaxial optic fiber connected to a xenon light source (Lausanne set, Oertli, Switzerland-developed at Jules Gonin, Lausanne, by Gonvers and Bovey). Separation of the posterior hyaloid membrane was performed when necessary. Visualization of the fundus was achieved with a special noncontact wide-angle viewing system 37 during vitrectomy and with a planoconcave contact lens for macular peeling. The MEM was peeled in the macular area using an end gripping forceps.
Other Name: vitrectomy(DORC)
prospective, interventional study and includes patients who underwent vitrectomy,peeling of an epiretinal membrane and internal limiting membrane excision with or without intraoperative intraocular ICG injection.
Excised specimens were placed on a Millipore filter, fixed in a paraformaldehyde solution, and examined by light and transmission electron microscopy. Ultrathin sections were stained with uranyl acetate-lead citrate and inspected in a Zeiss EM electron microscope. The assessment was done in a blinded, masked fashion so that the clinicians who reviewed the histologic specimens
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994227
|Korea, Republic of|
|Seoul, Korea, Republic of|