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Are Network Results Regarding Ocular Coherence Tomography (OCT) Relevant to Clinical Practice and Clinical Trials?

Are Network Results Regarding Ocular Coherence Tomography (OCT) Relevant to Clinical Practice and Clinical Trials? . Sponsored by the National Eye Institute, National Institutes of Health, U.S. Department of Health and Human Services. Comparison of CPT & VA at Baseline (A). 0. Correlation:.

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Are Network Results Regarding Ocular Coherence Tomography (OCT) Relevant to Clinical Practice and Clinical Trials?

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  1. Are Network Results Regarding Ocular Coherence Tomography (OCT) Relevant to Clinical Practice and Clinical Trials? Sponsored by the National Eye Institute, National Institutes of Health, U.S. Department of Health and Human Services.

  2. Comparison of CPT & VA at Baseline (A) 0 Correlation: r = 0.52, N = 251 20 (20/400) 40 (20/160) VA (Letter Score) 60 (20/63) 80 (20/25) 100 0 200 400 600 800 1000 OCT CPT (Microns)

  3. Comparison of CPT & VA at Baseline (A) 0 Correlation: r = 0.52, N = 251 20 (20/400) 40 (20/160) VA (Letter Score) 60 (20/63) 80 (20/25) 100 0 200 400 600 800 1000 OCT CPT (Microns)

  4. Comparison of CPT & VA at Baseline (A) 0 Correlation: r = 0.52, N = 251 20 (20/400) 40 (20/160) VA (Letter Score) 60 (20/63) 80 (20/25) 100 0 200 400 600 800 1000 OCT CPT (Microns)

  5. Comparison of Change in OCT CPT and Change in VA from Baseline to 3.5 Months 25 Thinner / Visual Acuity Better 20 Thicker / Visual Acuity Better (Paradoxical Change) 15 10 5 0 Change in VA (Letter Score) -5 -10 Thinner / Visual Acuity Worse -15 Thicker / Visual Acuity Worse (Paradoxical Change) Correlation: r = 0.44, N = 185 -20 -25 250 200 150 100 50 0 -50 -100 -150 -200 -250 Absolute Change in OCT CPT (Microns)

  6. Comparison of Change in OCT CPT and Change in VA from Baseline to 3.5 Months 25 Thinner / Visual Acuity Better 20 Thicker / Visual Acuity Better (Paradoxical Change) 15 10 5 0 Change in VA (Letter Score) -5 -10 Thinner / Visual Acuity Worse -15 Thicker / Visual Acuity Worse (Paradoxical Change) Correlation: r = 0.44, N = 185 -20 -25 250 200 150 100 50 0 -50 -100 -150 -200 -250 Absolute Change in OCT CPT (Microns)

  7. Summary • There is a modest correlation of OCT measured CPT with VA in eyes with diabetic macular edema (DME) • There is a wide range of visual acuities for a given CPT • There is a modest correlation of changes in retinal thickening and VA after focal laser treatment for DME • OCT measurement alone may not be a good surrogate for VA as a primary outcome in studies of DME Diabetic Retinopathy Clinical Research Network. Relationship between optical coherence tomography-measured central retinal thickness and visual acuity in diabetic macular edema. Ophthalmology 2007;114;525-36

  8. Other OCT Findings

  9. A ‘Real’ Change in ThicknessOCT Diurnal Variation Study (C)

  10. Summary • Change in central subfield thickness exceeding 11% is likely to be real • Replicate measurements of central subfield differ by a median of 2% in patients with DME • Retinal thickness reproducibility in microns varies according to the degree of thickness Diabetic Clinical Retinopathy Clinical Research Network. Reproducibility of macular thickness and volume using Zeiss optical coherence tomography in patients with diabetic macular edema. Ophthalmology 2007;114:1520-5

  11. Relationship of Error Rate by Scan Proportion Sent to RC Based on Center Point SD 16% 14% Never Send 12% 10% SD >= 10% 8% SD >= 9% Error Rate SD >= 7% 6% SD >= 5% 4% SD >= 3% 2% 0% 0% 20% 40% 60% 80% 100% Scans Sent to Reading Center

  12. Summary • In DME trials, error involved with automated OCT CPT measurement is sufficiently small that results are not likely to be affected if scans are not routinely sent a reading center • Greater degree of accuracy requires sending only about 1/3 of scans to the RC for assessment.

  13. Mean Retinal Thickness According to Gender in Diabetic Subjects with Minimal or No Retinopathy (G)

  14. Mean Retinal Thickness [Minimal or No Retinopathy (G)]

  15. Summary • OCT measured thickness in diabetic subjects without retinopathy are similar to central subfields OCT data in non-diabetic subjects • The nasal inner and outer zones are thicker than the temporal inner and outer zones

  16. Summary • The average central subfield is thicker in men than women. • Gender differences are large enough to consider separate norms by gender when designing clinical trials evaluating DME based on OCT Retinal thickness on Stratus™ optical coherence tomography in people with diabetes and minimal or no diabetic retinopathy. Am J Ophthalmol 2008 May;145(5):894-901

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