1 / 20

DRCR Cataract Studies

DRCR.net Cataract Studies. Carl Baker, M.D. Protocol Chair. Background. More than 1.5 million people undergo cataract operations in the US per year, of whom at least 15% have diabetes

blenda
Download Presentation

DRCR Cataract Studies

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. DRCR.net Cataract Studies Carl Baker, M.D. Protocol Chair

  2. Background • More than 1.5 million people undergo cataract operations in the US per year, of whom at least 15% have diabetes • There is limited data regarding VA outcomes and development/exacerbation of macular edema in individuals with diabetes undergoing cataract surgery • Reports suggest that macular edema after cataract surgery is a frequent problem, especially in eyes with pre-existing DME

  3. What We Want to Know • In eyes with pre-existing DME, would an interventional trial evaluating treatment with intravitreal injections be feasible for the Network? • In eyes without pre-existing DME, is post-surgical edema noted frequently enough to warrant a future interventional trial by the Network?

  4. Two Concurrent Observational Studies • Patients with diabetes undergoing cataract surgery • Treatment (pre-, peri-, and post-surgery and during follow-up) is at the discretion of cataract surgeon and investigator • Protocol P includes eyes with OCT CSF ≥ 250 • Protocol Q includes eyes with OCT CSF < 250

  5. Cataract Surgery • Coordinator confirms date of surgery • Cataract surgeons will not be considered investigators • Cataract surgery is by usual manner of the cataract surgeon • Surgery-related medical records (including treatment and post-op exams) obtained through medical record release

  6. Protocol P A Pilot Study in Individuals with Center-Involved DME Undergoing Cataract Surgery

  7. Study Objective • Primary Objective • Evaluate feasibility of aspects of the study design of a subsequent randomized trial • Secondary Objectives • Describe how cataract surgeons and DRCR.net investigators manage these cases at the time of surgery • Evaluation of VA and OCT CSF outcomes at 16 weeks

  8. Major Eligibility Criteria • Age ≥ 18 with diagnosis of diabetes • Visual acuity light perception or better • Cataract surgery scheduled within 1-14 days • OCT central subfield thickness ≥ 250 (Stratus, Cirrus, Spectralis, Topcon)

  9. Sample Size • Recruitment initially will be conducted over a period of 6 months • At 6 months a determination will be made whether to continue or stop enrollment • A maximum of 500 subjects will be enrolled, with a maximum of 20 subjects per site

  10. Baseline Testing • E-ETDRS Visual Acuity Testing in both eyes (including protocol refraction) • OCT in study eye • Ocular exam in study eye • Digital fundus photos in study eye (for at least first 50 subjects) • FA will be collected if part of routine care

  11. Follow-up Schedule • Cataract surgery within 1-14 days following enrollment • One follow-up visit at 16 weeks following cataract surgery. • The first time any post-surgical non-topical treatment for DME or CME is to be given, an OCT will be performed prior to administering treatment.

  12. 16-Week Visit Testing • E-ETDRS Visual Acuity Testing in both eyes (protocol refraction in study eye) • OCT in study eye • Ocular exam in study eye • FA will be collected if part of routine care

  13. Protocol Q An Observational Study in Individuals with Diabetic Retinopathy without Center-Involved DME Undergoing Cataract Surgery

  14. Study Objective • Primary Objective • In eyes with DR but no definite center-involved DME (either no DME or non-center involved DME), determine incidence of progression to center-involved DME 16 weeks after cataract surgery • Secondary Objectives • Evaluate baseline factors associated with progression to center-involved DME • Evaluate VA, OCT CSF, progression of DR, presence of DME/CME/Combination on FA

  15. Major Eligibility Criteria • Age ≥ 18 with diagnosis of diabetes • Visual acuity light perception or better • Cataract surgery scheduled within 28 days of baseline testing • MA or at least mild NPDR on clinical exam • OCT central subfield thickness < 250 (Stratus, Cirrus, Spectralis, Topcon)

  16. Sample Size • Recruitment is planned over a period of 24 months • At 6 months, distribution of enrolled eyes in predefined subgroups will be evaluated and a determination will be made whether to continue or stop enrollment • Overall, a maximum of 500 subjects will be enrolled (no restriction on # per site)

  17. Baseline Testing • E-ETDRS Visual Acuity Testing in both eyes (including protocol refraction) • OCT in study eye • Ocular exam in study eye • HbA1C testing

  18. Follow-up Schedule • Cataract surgery within 28 days following baseline testing • Follow-up visits at 4 and 16 weeks following cataract surgery. • The first time any post-surgical non-topical treatment for DME or CME is to be given, an OCT and FA will be performed prior to administering treatment.

  19. 4 and 16-Week Visit Testing • E-ETDRS Visual Acuity Testing in both eyes (protocol refraction in study eye) • OCT in study eye • Ocular exam in study eye • FA at 16-week visit only if OCT CSF ≥ 250 and non-topical DME/CME treatment has not been given

  20. Evaluation of FAs (P and Q) • If FA is collected during follow-up, the investigator will evaluate CME vs. DME using protocol specified criteria • Investigator evaluations will be compared to reading center evaluations • In Protocol P, the ability to classify DME vs CME will be evaluated to determine if the criteria can be used in determining treatment in a subsequent RCT

More Related