Intravitreal Aflibercept Injection or Early Vitrectomy for Diabetic Vitreous Hemorrhage

PHASE4CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

March 7, 2018

Primary Completion Date

July 22, 2019

Study Completion Date

September 29, 2019

Conditions
Diabetic Vitreous Hemorrhage
Interventions
DRUG

Aflibercept Injection [Eylea]

"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."

PROCEDURE

Vitrectomy

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.

Trial Locations (1)

123

Alhadi Hospital, Hawalli

All Listed Sponsors
lead

Al Hadi Hospital

OTHER

NCT04153253 - Intravitreal Aflibercept Injection or Early Vitrectomy for Diabetic Vitreous Hemorrhage | Biotech Hunter | Biotech Hunter