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

Not Applicable

Active, not recruiting

• Conditions: Vitreous Disorder; Cataract
• Interventions: Procedure: Cataract surgery; Procedure: Vitrectomy

• Registration Number: NCT05583331
• Lead Sponsor: Elsan

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.

Study Timeline

• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-17
• Study Start: 2022-12-15
• Primary Completion: 2023-08-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitrectomy then cataract surgery	Vitrectomy	Patients will undergo first the vitrectomy then the cataract surgery, as a combined surgery performed on the same day.
Cataract surgery then Vitrectomy	Cataract surgery	Patients will undergo first the cataract surgery then the vitrectomy, as a combined surgery performed on the same day.
Cataract surgery then Vitrectomy	Vitrectomy	Patients will undergo first the cataract surgery then the vitrectomy, as a combined surgery performed on the same day.
Vitrectomy then cataract surgery	Cataract surgery	Patients will undergo first the vitrectomy then the cataract surgery, as a combined surgery performed on the same day.

Primary Outcome Measures

Name	Time	Method
Intraoperative iris hernia occurence	During the combined surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut Ophtalmique de Somain; 🇫🇷 Somain, France