Using the Optovue OCT to Select IOL Power
| Tracking Information | |||||
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| First Received Date ICMJE | May 25, 2011 | ||||
| Last Updated Date | May 31, 2011 | ||||
| Start Date ICMJE | December 2010 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01361282 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 | Using the Optovue OCT to Select IOL Power | ||||
| Official Title ICMJE | Evaluation of Total Corneal Power Calculations for Intraocular Lens Selection Using the Optovue OCT in Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) Patients | ||||
| Brief Summary | Many patients with endothelial dysfunction also present with cataracts. It is therefore common practice to perform cataract extraction and intraocular lens (IOL) implantation during the same operation and immediately prior to Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK), in order to minimize trips to the operating room and the associated risks of ocular surgery. However, the unique posterior corneal anatomy of the DSAEK recipient makes it difficult to predict pre-operatively the proper power of IOL to place, and some patients end up with a mismatched lens that requires spectacle correction. The current gold standard for IOL power calculation (A-Scan optical biometry) takes measurements of the anterior surface of the cornea and makes assumptions about the posterior surface that are violated by the unique hourglass shape of the donor DSAEK graft. New optical coherence tomography (OCT) technology provides us with the ability to measure curvature in both the anterior and posterior aspects of the cornea in order to generate an IOL calculation that has the potential to give more accurate results for our DSAEK patients. The investigators will be using the Optovue to perform corneal power analysis on patients who have already received DSAEK and cataract surgery, in order to compare the post-op Optovue power calculations to the pre-operative power calculations provided by the A-Scan. If the OCT is shown to provide accurate IOL power calculations, then some patients might be better served by a two-stage procedure where DSAEK is performed and then followed six months later by cataract surgery using the OCT to calculate IOL power. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | All study subjects will have received Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) for Fuchs' Endothelial Dystrophy, together with concurrent cataract surgery. Data collection will occur between 6 and 18 months following surgery. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Triple Procedure
All qualifying patients will have received DSAEK with concurrent cataract extraction and intraocular lens placement. Data collection will occur between 6-18 months post-operation. |
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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 | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 54 | ||||
| Estimated Completion Date | December 2011 | ||||
| Estimated Primary Completion Date | December 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 and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01361282 | ||||
| Other Study ID Numbers ICMJE | LEBO-2011-1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Mark A. Terry, MD, Legacy Health System | ||||
| Study Sponsor ICMJE | Legacy Health System | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Legacy Health System | ||||
| Verification Date | May 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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