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Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy

NCT05514925 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-08-31

No results posted yet for this study

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.

Conditions

  • Proliferative Diabetic Retinopathy
  • Vitreous Hemorrhage
  • Tractional Retinal Detachment

Interventions

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.

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.

Sponsors & Collaborators

  • Khairallah Moncef

    lead OTHER

Principal Investigators

  • Imen Ksiaa, Assoc. Prof. · Fattouma Bourguiba University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-21
Primary Completion
2022-11-30
Completion
2022-12-31

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05514925 on ClinicalTrials.gov