Cataract, Diabetic Macular Edema
Conditions
Brief summary
The investigators aim to evaluate how different timing of anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-VEGF intravitreous affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.
Detailed description
Cataract is very common in diabetic patients and can lead to significant vision loss and disability without medical intervention. Diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. An increased risk in the development of post-operative cystoid macular edema and exacerbation of baseline DME is reported and this poses a significant challenge in managing concomitant DME and visually-significant cataracts. Goals of the study are to evaluate how different timing of anti-VEGF intravitreous injections (before operation, intra-operation or after-operation) affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of 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
DRUGLucentis
Lucentis 0.5 MG Per 0.05 ML Injection
Sponsors
Second Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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 , 6 months and 12 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. |
| Change in optical coherence tomography (OCT) central subfield (CSF) thickness | 24 hours post-operatively, 1 month, 3 months , 6 months and 12 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of postoperative injections | 12 months after cataract surgery | Total number of postoperative injections will be calculated |
| percentage of patients with diabetic retinopathy progression | 12 months after cataract surgery | patients with diabetic retinopathy progression will be calculated |
Countries
China
Contacts
Primary Contactdongyan pan
Backup Contactwei shen
Outcome results
None listed