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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lucentis injected Pre-operatively | Experimental | Lucentis injected 2 weeks before cataract surgery |
|
| Lucentis injected intra-operatively | Active Comparator | Lucentis injected during the course of the surgery by cataract surgeon. |
|
| Lucentis injected post-operatively | Experimental | Lucentis injected 2 weeks after cataract surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lucentis | Drug | Lucentis 0.5 MG Per 0.05 ML Injection |
|
| 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 , 6 months and 12 months after cataract surgery |
| 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 , 6 months and 12 months after cataract surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of postoperative injections | Total number of postoperative injections will be calculated | 12 months after cataract surgery |
| percentage of patients with diabetic retinopathy progression |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| dongyan pan | Contact | 86-21-31161995 | campus@126.com | |
| wei shen | Contact | 86-21-31161995 | shenwzz@163.com |
| Name | Affiliation | Role |
|---|---|---|
| wei shen | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | 86-21 | China |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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patients with diabetic retinopathy progression will be calculated
| 12 months after cataract surgery |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |