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| ID | Type | Description | Link |
|---|---|---|---|
| IORG0009738 N95 | Registry Identifier | Medicine Faculty of Monastir, Monastir University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative Anti-VEGF Intravitreal Injection | Active Comparator | Three to five days before vitrectomy, each participant received one intravitreal Bevacizumab injection (1.25 mg,0.05 ml). |
|
| Peripheral Retinal Cryoapplication | Experimental | Four to six weeks before vitrectomy, each participant underwent peripheral retinal cryoapplication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total surgical time | Duration of vitrectomy from the placement of the trocars until their removal | at the end of the vitrectomy |
| Intraoperative bleeding | occurrence of intravitreal bleeding during vitrectomy | at the end of the vitrectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative bleeding | occurrence of intravitreal bleeding after vitrectomy | one month after the vitrectomy |
| Visual acuity | Best corrected logMAR visual acuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Imen Ksiaa, Assoc. Prof. | Contact | +21694994234 | khay.imen@yahoo.fr |
| Name | Affiliation | Role |
|---|---|---|
| Imen Ksiaa, Assoc. Prof. | Fattouma Bourguiba University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fattouma Bourguiba University Hospital - Ophthalmology Department | Recruiting | Monastir | 5000 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23791371 | Background | Zhang ZH, Liu HY, Hernandez-Da Mota SE, Romano MR, Falavarjani KG, Ahmadieh H, Xu X, Liu K. Vitrectomy with or without preoperative intravitreal bevacizumab for proliferative diabetic retinopathy: a meta-analysis of randomized controlled trials. Am J Ophthalmol. 2013 Jul;156(1):106-115.e2. doi: 10.1016/j.ajo.2013.02.008. | |
| 31095954 |
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| ID | Term |
|---|---|
| D014823 | Vitreous Hemorrhage |
| ID | Term |
|---|---|
| D005130 | Eye Hemorrhage |
| D005128 | Eye Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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. |
|
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| one month after the vitrectomy |
| Arevalo JF, Lasave AF, Kozak I, Al Rashaed S, Al Kahtani E, Maia M, Farah ME, Cutolo C, Brito M, Osorio C, Navarro P, Wu L, Berrocal MH, Morales-Canton V, Serrano MA, Graue-Wiechers F, Sabrosa NA, Alezzandrini AA, Gallego-Pinazo R; Pan-American Collaborative Retina Study (PACORES) Group. Preoperative Bevacizumab for Tractional Retinal Detachment in Proliferative Diabetic Retinopathy: A Prospective Randomized Clinical Trial. Am J Ophthalmol. 2019 Nov;207:279-287. doi: 10.1016/j.ajo.2019.05.007. Epub 2019 May 13. |
| 3721714 | Background | Lim AS, Ang BC. Cryoapplication in diabetic retinopathy. Int Ophthalmol. 1986 May;9(2-3):139-41. doi: 10.1007/BF00159842. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |