Clinicopathologic Findings for Macular Disease

Not Applicable

Completed

• Conditions: Macular Disease
• Interventions: Procedure: vitrectomy for macular disease

• Registration Number: NCT00994227
• Lead Sponsor: Hallym University Medical Center

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2009-10
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Study Completion: 2010-06
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-20
• Last Update Posted: 2011-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients who underwent vitrectomy,peeling of an idiopathic MEM and ILM excision with or without intraoperative intraocular ICG injectio

Exclusion Criteria

• the presence of macular hole or lamellar macular hole previous vitreoretinal surgery the presence of any other macular pathologic features potentially interfering with histologic results (such as diabetic retinopathy or age-related macular degeneration).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
surgery	vitrectomy for macular disease	-

Primary Outcome Measures

Name	Time	Method
spectral domain optical coherence tomography	baseline, 1week, 1month, 3 month	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	baseline, 1 month, 3 months	logMAR

Secondary Outcome Measures

Name	Time	Method
electron microscopy finding of internal limiting membrane	during operation
visual field	baseline, postoperative 1 months, 3 months	humpley visual field
preferential hyperacuity perimeter	baseline, postoperative 1 months, 3 months	ForeseePHP 2.05; Notal Vision, Tel Aviv, Israel

Trial Locations

Locations (1)

JiWon Lim; 🇰🇷 Seoul, Korea, Republic of