NCT05514925

Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy

Peripheral Retinal Cryoapplication Versus Anti-VEGF Intravitreal Injection Before Vitrectomy for Complicated Proliferative Diabetic Retinopathy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Khairallah Moncef · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Pars-plana vitrectomy (PPV) is the cornerstone of surgical treatment of complicated proliferative diabetic retinopathy allowing the removal of vitreous opacity and releasing tractions from the retina. Surgical outcomes, however, are variable depending on a large array of pre, per, and post-operative conditions. The preoperative anti-VEGF intravitreal injection has shown a good effect on surgical outcomes in patients with vitreous hemorrhage or tractional retinal detachment. However, a great number of patients present with co-morbidities that contraindicate the usage of anti-VEGF in the pre-operative period. Thus, an alternative to this adjunctive therapy is worth investigating. In another hand, cryoapplication, an old therapeutic tool for proliferative diabetic retinopathy had been used in patients with non-clear ocular media with vitreous hemorrhage. The investigators present herein a comparative study between peripheral retinal cryoapplication and anti-VEGF before vitrectomy for complicated proliferative diabetic retinopathy.

Conditions

• Proliferative Diabetic Retinopathy
• Vitreous Hemorrhage
• Tractional Retinal Detachment

Interventions

Type	Name	Description
DRUG	Bevacizumab Injection [Avastin]	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.
PROCEDURE	Peripheral Retinal Cryoapplication	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.

Timeline

• Start date: 2017-11-21
• Primary completion: 2022-11-30
• Completion: 2022-12-31
• First posted: 2022-08-25
• Last updated: 2022-08-31

Locations

1 site across 1 country: Tunisia