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Prospective study comparing efficacy and safety of intravitreal aflibercept injection and panretinal photocoagulation to early vitrectomy for patients with diabetic vitreous hemorrhage.
Selected patients were divided into two groups, Group I for whom intravitreal aflibercept injection followed by panretinal photocoagulation was done and group II for whom early vitrectomy was done.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Active Comparator | Intravitreal injection of Aflibercept followed by panretinal photocoagulation. |
|
| Group II: Early vitrectomy. | Active Comparator | Early vitrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept Injection [Eylea] | Drug | Three monthly based intravitreal injections were given followed by PRP if the hemorrhage was sufficiently cleared.Intravitreal injection was done in sterile operating room, after sterilization and toweling with application of sterile speculum, Betadine 5% drops was instilled into the conjunctiva and kept for two minutes followed by wash with balanced salt solution. Injection of 2mg /0.05m aflibercept was given 4 mm from the limbus in phakic eyes and 3.5 mm in pseudophakic with compression by sterile cotton tip on the site of injection, Paracentesis was done in cases of very high IOP following injection. At the end of procedure check of visual acuity was done (to be at least light perception). PRP was done if the hemorrhage is sufficiently cleared after the third injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean best corrected visual acuity(BCVA) change in both groups. | Final BCVA change measured in log MAR compared to initial BCVA. | 9 months follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of recurrent bleeding. | Rate of recurrent vitreous hemorrhage in both groups after initial clearance. | 9 months follow up. |
| Number of additional treatment procedures . | Additional treatment procedures done in cases of recurrent hemorrhage in both groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed H Abdelhamid, MD | Alhadi hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alhadi Hospital | Hawalli | Aljabyria | 123 | Kuwait |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32252674 | Derived | Abd Elhamid AH, Mohamed AAEA, Khattab AM. Intravitreal Aflibercept injection with Panretinal photocoagulation versus early Vitrectomy for diabetic vitreous hemorrhage: randomized clinical trial. BMC Ophthalmol. 2020 Apr 6;20(1):130. doi: 10.1186/s12886-020-01401-4. |
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The data will be given from the author upon request.
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| ID | Term |
|---|---|
| C533178 | aflibercept |
| D014821 | Vitrectomy |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Vitrectomy | Procedure | Was done under local peribulbar anesthesia. After sterilization and toweling, wash with diluted betadine 5% was done. Insertion of three 23 valved cannulas beginning with the lower temporal one for infusion, clearance of anterior vitreous was done followed by core vitrectomy, peripheral vitrectomy , removal of posterior hyaloid aided by triamcinolone staining , trimming and removal of any vascular epicenters followed by vitreous base shaving with 360 scleral indentation, endolaser treatment was done for all eyes followed by fluid air exchange, 20% SF6 was used only if there is active significant bleeding during surgery or if there is intraoperative retinal tears, removal of cannulas was done at the end of surgery. All eyes received combination of topical steroid and antibiotic eye drops as postoperative treatment. |
|
| 9 months follow up |