Microperimetry and Optical Coherence Tomography (OCT) in Idiopathic Epiretinal Membrane
This study has been completed.
Sponsor:
Centre Hospitalier Universitaire Dijon
Information provided by (Responsible Party):
Nicot Frederic, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01481987
First received: November 21, 2011
Last updated: November 29, 2011
Last verified: November 2011
| Tracking Information | |||||
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| First Received Date ICMJE | November 21, 2011 | ||||
| Last Updated Date | November 29, 2011 | ||||
| Start Date ICMJE | January 2011 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Macular sensitivity [ Time Frame: 12 months ] [ Designated as safety issue: No ] The objective of this study was to assess macular function by measuring its sensitivity using microperimetry in patients with idiopathic ERM every three months up to one year. We compared the results of macular sensitivity to the best-corrected visual acuity (BCVA) and the OCT data to better understand the structure-function relationship. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01481987 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Microperimetry and Optical Coherence Tomography (OCT) in Idiopathic Epiretinal Membrane | ||||
| Official Title ICMJE | Retinal Sensitivity and Optical Coherence Tomography Findings in Eyes With Idiopathic Epiretinal Membrane | ||||
| Brief Summary | Purpose: To evaluate macular sensitivity and its correlation with visual acuity and Spectral Domain Optical Coherence Tomography (SD-OCT) in eyes with idiopathic epiretinal membrane (ERM). Design: Cross sectional case-control series. Methods: Setting: Dijon University Hospital. Patients: Forty nine patients (49 eyes) with idiopathic ERM and twenty-seven healthy patients (27 eyes) as a control group. Main outcome measurement: Microperimetry, Spectral Domain Optical Coherence Tomography (SD-OCT). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Epiretinal Membrane | ||||
| Intervention ICMJE | Procedure: Epiretinal Membrane Surgical treatment
epiretinal membrane peeling |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 76 | ||||
| Completion Date | September 2011 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01481987 | ||||
| Other Study ID Numbers ICMJE | Rodica 01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Nicot Frederic, Centre Hospitalier Universitaire Dijon | ||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire Dijon | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire Dijon | ||||
| Verification Date | November 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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