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

NCT05583331 | Completed

• 2 other identifiers: VICAR2022-A00886-37
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Vitreous Disorder

Outcome Measures

Primary Outcomes (1)

• Intraoperative iris hernia occurence

  During the combined surgery

Secondary Outcomes (6)

• 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.

Study Arms (2)

Cataract surgery then Vitrectomy

ACTIVE COMPARATOR

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

Procedure: Cataract surgery; Procedure: Vitrectomy

Vitrectomy then cataract surgery

EXPERIMENTAL

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

Procedure: Cataract surgery; Procedure: Vitrectomy

Interventions

Cataract surgery PROCEDURE

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

Cataract surgery then Vitrectomy; Vitrectomy then cataract surgery

Vitrectomy PROCEDURE

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

Cataract surgery then Vitrectomy; Vitrectomy then cataract surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Institut Ophtalmique de Somain

Somain, 59490, France

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction; Vitrectomy

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, randomised, double-arms, parallel, open-label study.

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: December 15, 2022
• Primary Completion: September 29, 2023
• Study Completion: December 29, 2023
• Last Updated: September 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)