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Intravitreal Aflibercept Injection or Early Vitrectomy for Diabetic Vitreous Hemorrhage

NCT04153253 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-01-14

No results posted yet for this study

Summary

Prospective study comparing efficacy and safety of intravitreal aflibercept injection and panretinal photocoagulation to early vitrectomy for patients with diabetic vitreous hemorrhage.

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.

Sponsors & Collaborators

  • Al Hadi Hospital

    lead OTHER

Principal Investigators

  • Ahmed H Abdelhamid, MD · Alhadi hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2019-07-22
Completion
2019-09-29

Countries

  • Kuwait

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04153253 on ClinicalTrials.gov