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

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Vitreous Disorder
• Intervention / Treatment: Procedure: Cataract surgery; Procedure: Vitrectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Somain, France, 59490
    • Institut Ophtalmique de Somain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cataract surgery then Vitrectomy; Patients will undergo first the cataract surgery then the vitrectomy, as a combined surgery performed on the same day.	Procedure: Cataract surgery; Cataract surgery will be performed as per local practice and standard guidelines.; Procedure: Vitrectomy; Vitrectomy will be performed as per local practice and standard guidelines.
Experimental: Vitrectomy then cataract surgery; Patients will undergo first the vitrectomy then the cataract surgery, as a combined surgery performed on the same day.	Procedure: Cataract surgery; Cataract surgery will be performed as per local practice and standard guidelines.; Procedure: Vitrectomy; Vitrectomy will be performed as per local practice and standard guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraoperative iris hernia occurence	During the combined surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Other intraoperative complications occurence	During the combined surgery
Post-operative complications occurence	At 6 months after the combined surgery
Combined surgery duration in minutes	At the end of the combined surgery
Ocular hypertension occurence	At 1 month, 3 months and 6 months after combined surgery
Combined Surgery-related costs assessment	At the time of the combined surgery.
Visual acuity assessment	At 6 months after combined surgery.

Collaborators and Investigators

• Sponsor: Elsan

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): December 29, 2023

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: VICAR; 2022-A00886-37 (Other Identifier: ANSM)

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
• product manufactured in and exported from the U.S.: No