Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy
NCT ID: NCT05514925
Last Updated: 2022-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2017-11-21
2022-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Preoperative Anti-VEGF Intravitreal Injection
Three to five days before vitrectomy, each participant received one intravitreal Bevacizumab injection (1.25 mg,0.05 ml).
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.
Peripheral Retinal Cryoapplication
Four to six weeks before vitrectomy, each participant underwent peripheral retinal cryoapplication.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Previous vitrectomy
* Contraindication to anti-VEGF therapy or retinal cryoapplication
* Associated rhegmatogenous retinal detachment
18 Years
ALL
No
Sponsors
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Khairallah Moncef
OTHER
Responsible Party
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Khairallah Moncef
Clinical Professor
Principal Investigators
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Imen Ksiaa, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Fattouma Bourguiba University Hospital
Locations
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Fattouma Bourguiba University Hospital - Ophthalmology Department
Monastir, , Tunisia
Countries
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Central Contacts
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Facility Contacts
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Imen Ksiaa, Assoc. Prof.
Role: primary
References
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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.
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.
Lim AS, Ang BC. Cryoapplication in diabetic retinopathy. Int Ophthalmol. 1986 May;9(2-3):139-41. doi: 10.1007/BF00159842.
Other Identifiers
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IORG0009738 N95
Identifier Type: REGISTRY
Identifier Source: secondary_id
LR18SP09 N01
Identifier Type: -
Identifier Source: org_study_id