Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy

Sponsor

Khairallah Moncef (Other)

Overall Status

Recruiting

CT.gov ID

NCT05514925

Collaborator

(none)

Enrollment

Location

Arms

61.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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. We present herein a comparative study between peripheral retinal cryoapplication and anti-VEGF before vitrectomy for complicated proliferative diabetic retinopathy.

Condition or Disease	Intervention/Treatment	Phase
Proliferative Diabetic Retinopathy Vitreous Hemorrhage Tractional Retinal Detachment	Drug: Bevacizumab Injection [Avastin] Procedure: Peripheral Retinal Cryoapplication	Phase 4

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.

We present herein a comparative study between peripheral retinal cryoapplication and anti-VEGF before vitrectomy for complicated proliferative diabetic retinopathy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 21, 2017

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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).	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. Other Names: IVB
Experimental: Peripheral Retinal Cryoapplication Four to six weeks before vitrectomy, each participant underwent peripheral retinal cryoapplication.	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. Other Names: CRYO

Arm

Intervention/Treatment

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).

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.

Other Names:

IVB

Experimental: Peripheral Retinal Cryoapplication

Four to six weeks before vitrectomy, each participant underwent peripheral retinal cryoapplication.

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.

Other Names:

CRYO

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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