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The study team was unable to secure sufficient funding and administrative support.
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Goals of the study are to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.
Along with age, diabetes is a major risk factor for cataract formation, which can lead to significant vision loss and disability without medical intervention. Unfortunately, diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. Reasons for this is multifactorial but includes an increased risk in the development of post-operative cystoid macular edema, and exacerbation of baseline DME. This poses a significant challenge in managing concomitant DME and visually-significant cataracts.
Goals of the study are to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept injected Pre- and Post-operatively | Experimental | Pre- and Post-operative time of Aflibercept injections |
|
| Aflibercept injected intraoperatively | Active Comparator | Intraoperative time of Aflibercept injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept injected Pre- and Post-operatively | Drug | Three injections of aflibercept before cataract surgery, and aflibercept injections after surgery within 14-21 days of the day of surgery (number of injections depends on clinical exam findings, visual acuity and retinal thickness). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in best-corrected visual acuity (BCVA) | BCVA is a measurement of the best vision correction that can be achieved, such as glasses, as measured on the standard Snellen eye chart. For example, if uncorrected eyesight is 20/200, but patient can see 20/20 with glasses, the BCVA is 20/20. | 1 month, 3 months and 6 months after cataract surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in optical coherence tomography (OCT) central subfield (CSF) thickness | Optical coherence tomography (OCT) is an important imaging modality in the evaluation and management of retinal diseases. Change in central subfield (CSF) thickness will be measured and recorded. | 24 hours post-operatively, 1 month, 3 months and 6 months after cataract surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Hendrick, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Clinic | Atlanta | Georgia | 30322 | United States | ||
| Grady Health System |
No individual de-identified participant data (including data dictionaries) will be shared. Only composite results with publication will be shared.
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Aflibercept injected intraoperatively | Drug | Three injections of aflibercept before surgery and one injection of aflibercept during the course of the surgery by cataract surgeon. |
|
|
| Total number of postoperative injections | Total number of postoperative injections will be calculated | 6 months after cataract surgery |
| Atlanta |
| Georgia |
| 30322 |
| United States |