Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy

August 25, 2022 updated by: Khairallah Moncef

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Tunisia
      • Monastir, Tunisia, 5000
        • Recruiting
        • Fattouma Bourguiba University Hospital - Ophthalmology Department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total surgical time
Time Frame: at the end of the vitrectomy
Duration of vitrectomy from the placement of the trocars until their removal
at the end of the vitrectomy
Intraoperative bleeding
Time Frame: at the end of the vitrectomy
occurrence of intravitreal bleeding during vitrectomy
at the end of the vitrectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative bleeding
Time Frame: one month after the vitrectomy
occurrence of intravitreal bleeding after vitrectomy
one month after the vitrectomy
Visual acuity
Time Frame: one month after the vitrectomy
Best corrected logMAR visual acuity
one month after the vitrectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khairallah Moncef

Investigators

  • Principal Investigator: Imen Ksiaa, Assoc. Prof., Fattouma Bourguiba University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2017

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 25, 2022

Study Record Updates

Last Update Posted (Actual)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LR18SP09 N01
  • IORG0009738 N95 (Registry Identifier: Medicine Faculty of Monastir, Monastir University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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