Skip to content

Clinicopathologic Findings for Macular Disease

Clinicopathologic Findings for Macular Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00994227
Enrollment
60
Registered
2009-10-14
Start date
2009-05-31
Completion date
2010-06-30
Last updated
2011-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Disease

Keywords

electron microscopy, internal limiting membrane, macular disease, optical coherence tomography

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

Interventions

PROCEDUREvitrectomy 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.

Sponsors

Hallym University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
spectral domain optical coherence tomographybaseline, 1week, 1month, 3 monthThe 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 acuitybaseline, 1 month, 3 monthslogMAR

Secondary

MeasureTime frameDescription
electron microscopy finding of internal limiting membraneduring operation
visual fieldbaseline, postoperative 1 months, 3 monthshumpley visual field
preferential hyperacuity perimeterbaseline, postoperative 1 months, 3 monthsForeseePHP 2.05; Notal Vision, Tel Aviv, Israel

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026