Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy

Phase 4

• Conditions: Tractional Retinal Detachment; Proliferative Diabetic Retinopathy; Vitreous Hemorrhage
• Interventions: Drug: Bevacizumab Injection [Avastin]; Procedure: Peripheral Retinal Cryoapplication

• Registration Number: NCT05514925
• Lead Sponsor: Khairallah Moncef

Brief 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.

Study Timeline

• Study Start: 2017-11-21
• Status Verified: 2022-08
• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-25
• Last Update Submitted: 2022-08-25
• Last Update Posted: 2022-08-31
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Type 1 or 2 diabetes mellitus
• Vitreous or retro-hyaloidal hemorrhage and/or tractional retinal detachment threatening or involving the macula
• No or less than 1000 impacts of preoperative retinal photocoagulation and/or iris rubeosis
• Only one eye per participant

Exclusion Criteria

• Negative light perception
• Previous vitrectomy
• Contraindication to anti-VEGF therapy or retinal cryoapplication
• Associated rhegmatogenous retinal detachment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative Anti-VEGF Intravitreal Injection	Bevacizumab Injection [Avastin]	Three to five days before vitrectomy, each participant received one intravitreal Bevacizumab injection (1.25 mg,0.05 ml).
Peripheral Retinal Cryoapplication	Peripheral Retinal Cryoapplication	Four to six weeks before vitrectomy, each participant underwent peripheral retinal cryoapplication.

Primary Outcome Measures

Name	Time	Method
Intraoperative bleeding	at the end of the vitrectomy	occurrence of intravitreal bleeding during vitrectomy
Total surgical time	at the end of the vitrectomy	Duration of vitrectomy from the placement of the trocars until their removal

Secondary Outcome Measures

Name	Time	Method
Postoperative bleeding	one month after the vitrectomy	occurrence of intravitreal bleeding after vitrectomy
Visual acuity	one month after the vitrectomy	Best corrected logMAR visual acuity

Trial Locations

Locations (1)

Fattouma Bourguiba University Hospital - Ophthalmology Department; 🇹🇳 Monastir, Tunisia