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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cataract, Vitreous Disorder

Intervention / Treatment
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* Procedure: Cataract surgery
* Procedure: Vitrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, randomised, double-arms, parallel, open-label study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cataract surgery then Vitrectomy<br>Patients will undergo first the cataract surgery then the vitrectomy, as a combined surgery performed on the same day. | Procedure: Cataract surgery<br>* Cataract surgery will be performed as per local practice and standard guidelines.<br>Procedure: Vitrectomy<br>* Vitrectomy will be performed as per local practice and standard guidelines.<br>|
| Experimental: Vitrectomy then cataract surgery<br>Patients will undergo first the vitrectomy then the cataract surgery, as a combined surgery performed on the same day. | Procedure: Cataract surgery<br>* Cataract surgery will be performed as per local practice and standard guidelines.<br>Procedure: Vitrectomy<br>* Vitrectomy will be performed as per local practice and standard guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative iris hernia occurence |  | During the combined surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Visual acuity assessment |  | At 6 months after combined surgery. |