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

NCT ID: NCT05583331

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2023-12-29

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.

Conditions

Cataract; Vitreous Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cataract surgery then Vitrectomy

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

Group Type: ACTIVE_COMPARATOR

Cataract surgery

Intervention Type: PROCEDURE

Cataract surgery will be performed as per local practice and standard guidelines.

Vitrectomy

Intervention Type: PROCEDURE

Vitrectomy will be performed as per local practice and standard guidelines.

Vitrectomy then cataract surgery

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

Group Type: EXPERIMENTAL

Cataract surgery

Intervention Type: PROCEDURE

Cataract surgery will be performed as per local practice and standard guidelines.

Vitrectomy

Intervention Type: PROCEDURE

Vitrectomy will be performed as per local practice and standard guidelines.

Interventions

Cataract surgery

Cataract surgery will be performed as per local practice and standard guidelines.

Intervention Type: PROCEDURE

Vitrectomy

Vitrectomy will be performed as per local practice and standard guidelines.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elsan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Ophtalmique de Somain

Somain, , France

Countries

France

Other Identifiers

2022-A00886-37

Identifier Type: OTHER

Identifier Source: secondary_id

VICAR

Identifier Type: -

Identifier Source: org_study_id