Clinicopathologic Findings for Macular Disease
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 13, 2009
CompletedFirst Posted
Study publicly available on registry
October 14, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedApril 21, 2011
April 1, 2011
5 months
October 13, 2009
April 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
best corrected visual acuity
logMAR
baseline, 1 month, 3 months
Secondary Outcomes (3)
electron microscopy finding of internal limiting membrane
during operation
visual field
baseline, postoperative 1 months, 3 months
preferential hyperacuity perimeter
baseline, postoperative 1 months, 3 months
Study Arms (1)
surgery
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- patients who underwent vitrectomy,peeling of an idiopathic MEM and ILM excision with or without intraoperative intraocular ICG injectio
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
JiWon Lim
Seoul, South Korea
Related Publications (1)
Lim JW, Kim HK, Cho DY. Macular function and ultrastructure of the internal limiting membrane removed during surgery for idiopathic epiretinal membrane. Clin Exp Ophthalmol. 2011 Jan;39(1):9-14. doi: 10.1111/j.1442-9071.2010.02377.x.
PMID: 20662848DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 13, 2009
First Posted
October 14, 2009
Study Start
May 1, 2009
Primary Completion
October 1, 2009
Study Completion
June 1, 2010
Last Updated
April 21, 2011
Record last verified: 2011-04