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OpenTrials
Completed

NCT Number: NCT00994227

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.

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Key information

Conditions

Macular Disease Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

JiWon Lim

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

vitrectomy for macular disease

Procedure

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 names: vitrectomy(DORC)

Primary outcomes

  1. spectral domain optical coherence tomography

    Time frame: 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

  2. best corrected visual acuity

    Time frame: baseline, 1 month, 3 months

    logMAR

Secondary outcomes

  1. electron microscopy finding of internal limiting membrane

    Time frame: during operation

  2. visual field

    Time frame: baseline, postoperative 1 months, 3 months

    humpley visual field

  3. preferential hyperacuity perimeter

    Time frame: baseline, postoperative 1 months, 3 months

    ForeseePHP 2.05; Notal Vision, Tel Aviv, Israel

Sponsors and collaborators

Lead sponsor

Hallym University Medical Center

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Oct 14, 2009
Registry last updated
Apr 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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