Cataract, Diabetic Macular Edema
Conditions
Keywords
anti-VEGF injections, pre-existing DME, cataract surgery
Brief summary
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.
Detailed description
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.
Interventions
DRUGAflibercept injected Pre- and Post-operatively
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).
DRUGAflibercept injected intraoperatively
Three injections of aflibercept before surgery and one injection of aflibercept during the course of the surgery by cataract surgeon.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults over age 18 with diabetes mellitus, diabetic macular edema and visually significant cataracts planning to undergo cataract surgery
Exclusion criteria
* Patients who have undergone panretinal photocoagulation (PRP) in prior 4 months or an ocular condition (other than cataract and DME) that might affect visual acuity during course of study. * Patients with history of vitrectomy. * Patients with neovascular glaucoma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in best-corrected visual acuity (BCVA) | 1 month, 3 months and 6 months after cataract surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in optical coherence tomography (OCT) central subfield (CSF) thickness | 24 hours post-operatively, 1 month, 3 months and 6 months after cataract surgery | 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. |
| Total number of postoperative injections | 6 months after cataract surgery | Total number of postoperative injections will be calculated |
Countries
United States
Outcome results
None listed