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Comparison of Two Surgical Sequences "Cataract Surgery Then Vitrectomy" Versus "Vitrectomy Then Cataract Surgery" Under Local-regional Anesthesia (VICAR)

Primary Purpose

Cataract, Vitreous Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cataract surgery
Vitrectomy
Sponsored by
Elsan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Man or woman aged 18 years old or more
  • Patient with macular disease requiring vitrectomy
  • Patient with cataract requiring surgery
  • Patient suitable for local-regional anesthesia
  • Patient suitable for undergoing both surgical procedures consecutively and in any order
  • Patient that have given informed consent before performing any study-related procedure
  • Patient affiliated to a social security scheme

Exclusion Criteria:

  • Pseudophakic patients
  • Contra-indications to local-regional anesthesia
  • Pregnant or breastfeeding patients
  • Patients under legal protection

Sites / Locations

  • Institut Ophtalmique de SomainRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cataract surgery then Vitrectomy

Vitrectomy then cataract surgery

Arm Description

Patients will undergo first the cataract surgery then the vitrectomy, as a combined surgery performed on the same day.

Patients will undergo first the vitrectomy then the cataract surgery, as a combined surgery performed on the same day.

Outcomes

Primary Outcome Measures

Intraoperative iris hernia occurence

Secondary Outcome Measures

Other intraoperative complications occurence
Post-operative complications occurence
Combined surgery duration in minutes
Ocular hypertension occurence
Combined Surgery-related costs assessment
Visual acuity assessment

Full Information

First Posted
October 13, 2022
Last Updated
February 20, 2023
Sponsor
Elsan
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1. Study Identification

Unique Protocol Identification Number
NCT05583331
Brief Title
Comparison of Two Surgical Sequences "Cataract Surgery Then Vitrectomy" Versus "Vitrectomy Then Cataract Surgery" Under Local-regional Anesthesia
Acronym
VICAR
Official Title
Comparison of Two Surgical Sequences "Cataract Surgery Then Vitrectomy" Versus "Vitrectomy Then Cataract Surgery" Under Local-regional Anesthesia. A Pilot, Exploratory, Monocentric, Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elsan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cataracts and vitreo-retinal conditions are frequently associated and can lead to a combined surgery to treat both diseases at the same time. To date, in most cases cataract surgery is usually performed first, then followed by vitrectomy. However, there isn't any standard guidelines indicating what would be the best chronological order, or sequence, when performing those procedures. This randomised, double-arm, open-label study aims at investigating whether the sequence "cataract surgery then vitrectomy" or "vitrectomy then cataract surgery" can have an impact on iris hernia occurence.
Detailed Description
Cataracts and vitreo-retinal conditions are frequently associated, such as epimacular membranes, vitreomacular tractions, macular holes, or even macular edema. Cataract is also a frequent complication of posterior vitrectomy. Surgical treatment for pre- or post-vitrectomy cataract is corneal phacoemulsification with intraocular lens implantation. Many patients undergoing vitrectomy alone consult five to ten years later, without useful vision due to a dense cataract that might be more complicated to treat at a late stage. Indeed, if the phacoemulsification on a previously vitrectomized eye is not an issue in the first years, the intervention can be complicated ten years later, due to nuclear hardness and zonular weakness. To date, there are no recommendations regarding the surgical sequence for the combination of cataract surgery and vitrectomy. The most-used sequence is to start with cataract surgery and then to perform the vitrectomy most often in 25 gauges (retinal surgery). When we start with cataract surgery under locoregional anesthesia, we often have (in about 15% of cases) iris hernia, which causes intraoperative discomfort (need to put stitches on the cornea), intraoperative miosis, pigments release, which can interfere with visualization during vitrectomy and which require dilating agents use. The hypothesis of this study is that reversing the order of interventions and starting with vitrectomy could in particular reduce the incidence of intraoperative and postoperative complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Vitreous Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, randomised, double-arms, parallel, open-label study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cataract surgery then Vitrectomy
Arm Type
Active Comparator
Arm Description
Patients will undergo first the cataract surgery then the vitrectomy, as a combined surgery performed on the same day.
Arm Title
Vitrectomy then cataract surgery
Arm Type
Experimental
Arm Description
Patients will undergo first the vitrectomy then the cataract surgery, as a combined surgery performed on the same day.
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
Cataract surgery will be performed as per local practice and standard guidelines.
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy
Intervention Description
Vitrectomy will be performed as per local practice and standard guidelines.
Primary Outcome Measure Information:
Title
Intraoperative iris hernia occurence
Time Frame
During the combined surgery
Secondary Outcome Measure Information:
Title
Other intraoperative complications occurence
Time Frame
During the combined surgery
Title
Post-operative complications occurence
Time Frame
At 6 months after the combined surgery
Title
Combined surgery duration in minutes
Time Frame
At the end of the combined surgery
Title
Ocular hypertension occurence
Time Frame
At 1 month, 3 months and 6 months after combined surgery
Title
Combined Surgery-related costs assessment
Time Frame
At the time of the combined surgery.
Title
Visual acuity assessment
Time Frame
At 6 months after combined surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Man or woman aged 18 years old or more Patient with macular disease requiring vitrectomy Patient with cataract requiring surgery Patient suitable for local-regional anesthesia Patient suitable for undergoing both surgical procedures consecutively and in any order Patient that have given informed consent before performing any study-related procedure Patient affiliated to a social security scheme Exclusion Criteria: Pseudophakic patients Contra-indications to local-regional anesthesia Pregnant or breastfeeding patients Patients under legal protection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nabil TARIGHT, MD
Phone
(0)3 27 99 88 88
Ext
+33
Email
nabil.taright@institut-ophtalmique.fr
Facility Information:
Facility Name
Institut Ophtalmique de Somain
City
Somain
ZIP/Postal Code
59490
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabil TARIGHT, MD
Phone
(0)3 27 99 88 88
Ext
+33
Email
nabil.taright@institut-ophtalmique.fr
First Name & Middle Initial & Last Name & Degree
Nabil TARIGHT, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Two Surgical Sequences "Cataract Surgery Then Vitrectomy" Versus "Vitrectomy Then Cataract Surgery" Under Local-regional Anesthesia

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