Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy

Sponsor
Khairallah Moncef
Study ID
NCT05514925
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab Injection [Avastin] — DRUG
    Intravitreal injection of bevacizumab (1.25 mg, 0.05 ml) in the inferior temporal quadrant of the eye, 4 mm behind the limbus in phakic eyes, and 3.5 mm in pseudophakic eyes.
  • Peripheral Retinal Cryoapplication — PROCEDURE
    In the operating room under peribulbar anesthesia, four focal conjunctival incisions are made on each quadrant between the muscles insertions. The Tenon capsule is opened with scissors to expose the sclera. Four to six cryo-applications are made per quadrant, at the edge of muscle insertion and a line behind. The exposure time is 4 to 5 seconds. 7-0 resorbable sutures are then put on each quadrant to close the conjunctiva.

Study Details

Pars-plana vitrectomy (PPV) is the cornerstone of surgical treatment for eyes with complicated proliferative diabetic retinopathy. Anti-VEGF intravitreal injection before PPV has shown a good effect on surgical outcomes. However, many patients present with co-morbidities that contraindicate the usage of anti-VEGF in the pre-operative period. Thus, cryoapplication, an old therapeutic tool for proliferative diabetic retinopathy may be a good alternative. The investigators present herein a comparative study between peripheral retinal cryoapplication and anti-VEGF before vitrectomy for complicated proliferative diabetic retinopathy.

Key Dates

First listed
Aug 25, 2022
Start date
Nov 21, 2017
Status verified
Aug 2022
Primary completion
Nov 30, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Preoperative Anti-VEGF Intravitreal Injection
    Three to five days before vitrectomy, each participant received one intravitreal Bevacizumab injection (1.25 mg,0.05 ml).
  • Experimental: Peripheral Retinal Cryoapplication
    Four to six weeks before vitrectomy, each participant underwent peripheral retinal cryoapplication.

Primary Outcome Measure

Total surgical time [ Time Frame: at the end of the vitrectomy ]

Central Contacts