Proliferative Diabetic Retinopathy, Vitreous Hemorrhage, Tractional Retinal Detachment
Conditions
Keywords
Retinal cryoapplication, Anti-VEGF, Vitrectomy
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.
Interventions
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.
PROCEDUREPeripheral 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.
Sponsors
Khairallah Moncef
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Tunisia
Contacts
Primary ContactImen Ksiaa, Assoc. Prof.
Outcome results
None listed