Clinicopathologic Findings for Macular Disease

Macular Disease Clinical Trial

Official title:

Clinicopathologic Findings for Macular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994227
• Other study ID #: 2009-10-10
• Status: Completed
• Phase: N/A
• First received: October 13, 2009
• Last updated: April 20, 2011
• Start date: May 2009
• Est. completion date: June 2010

Study information

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

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Macular Disease

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	JiWon Lim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spectral domain optical coherence tomography	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	baseline, 1week, 1month, 3 month	Yes
Primary	best corrected visual acuity	logMAR	baseline, 1 month, 3 months	Yes
Secondary	electron microscopy finding of internal limiting membrane		during operation	Yes
Secondary	visual field	humpley visual field	baseline, postoperative 1 months, 3 months	Yes
Secondary	preferential hyperacuity perimeter	ForeseePHP 2.05; Notal Vision, Tel Aviv, Israel	baseline, postoperative 1 months, 3 months	Yes