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

Cataract Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05583331
• Other study ID #: VICAR
• Secondary ID: 2022-A00886-37
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Elsan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: June 2024
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Vitreous Disorder

Intervention

Procedure:
• Cataract surgery
Cataract surgery will be performed as per local practice and standard guidelines.
• Vitrectomy
Vitrectomy will be performed as per local practice and standard guidelines.

Locations

Country	Name	City	State
France	Institut Ophtalmique de Somain	Somain

Sponsors (1)

Lead Sponsor	Collaborator
Elsan

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative iris hernia occurence		During the combined surgery
Secondary	Other intraoperative complications occurence		During the combined surgery
Secondary	Post-operative complications occurence		At 6 months after the combined surgery
Secondary	Combined surgery duration in minutes		At the end of the combined surgery
Secondary	Ocular hypertension occurence		At 1 month, 3 months and 6 months after combined surgery
Secondary	Combined Surgery-related costs assessment		At the time of the combined surgery.
Secondary	Visual acuity assessment		At 6 months after combined surgery.