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Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery
This study has been completed.
Sponsor:
Kyorin University
Information provided by (Responsible Party):
Makoto Inoue, Kyorin University
ClinicalTrials.gov Identifier:
NCT01549249
First received: March 6, 2012
Last updated: November 12, 2012
Last verified: November 2012
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Purpose
The recovery of the cone outer segment tips (COST) line after epiretinal membrane (ERM) surgery using spectral-domain optical coherence tomography (SD-OCT) was assessed.
| Condition | Intervention |
|---|---|
| Epiretinal Membrane | Device: optical coherence tomography |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Single (Investigator) Primary Purpose: Treatment |
| Official Title: | Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery |
Further study details as provided by Makoto Inoue, Kyorin University:
Primary Outcome Measures:
- best-corrected visual acuity [ Time Frame: one year ]
Secondary Outcome Measures:
- Integrity and defect length of the photoreceptor layer detected by spectral-domain optical coherence tomography [ Time Frame: one year ]
| Enrollment: | 333 |
| Study Start Date: | June 2008 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: vitrectomy |
Device: optical coherence tomography
spectral-domain optical coherence tomography
Other Name: vitreous surgery
|
Detailed Description:
Epiretinal membrane (ERM) may cause decreased central vision or metamorphopsia. Pars plana vitrectomy with membrane peeling has become the standard treatment for epiretinal membrane. However, visual recovery or symptomatic relief is not always satisfactory in all eyes despite successful membrane removal. Spectral domain optical coherence tomography (SD-OCT) is a non-invasive imaging device for various vitreoretinal diseases. Cone outer segment tips (COST) line is a line observed between IS/OS line and RPE in SD-OCT. The investigators examined the correlation of visual acuity and the recovery of photoreceptor layer after ERM surgery, taking COST line into account as a new parameter
Eligibility| Ages Eligible for Study: | 40 Years to 90 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who received epiretinal membrane surgery between June, 2008, and November, 2010, at Kyorin Eye Center.
- Only eyes with postoperative follow-up period more than 6 months were included.
Exclusion Criteria:
- Eyes with secondary epiretinal membrane (previous history of uveitis, intraocular surgery, pre-operatively noted retinal breaks, etc.) were excluded.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01549249
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549249
Locations
| Japan | |
| Kyorin Eye Center | |
| Mitaka, Tokyo, Japan, 181-8611 | |
Sponsors and Collaborators
Kyorin University
Investigators
| Principal Investigator: | Makoto Inoue, MD | Kyorin Eye Center |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Makoto Inoue, Associate professor, Kyorin University |
| ClinicalTrials.gov Identifier: | NCT01549249 History of Changes |
| Other Study ID Numbers: |
KyorinEye007 |
| Study First Received: | March 6, 2012 |
| Last Updated: | November 12, 2012 |
Keywords provided by Makoto Inoue, Kyorin University:
|
cone outer segment tips line inner segment/outer segment junction line optical coherence tomography epiretinal membrane |
Additional relevant MeSH terms:
|
Epiretinal Membrane Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on September 21, 2017