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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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