Clinical trial NCT05583331: Comparison of Two Surgical Sequences "Cataract Surgery Then Vitrectomy" Versus "Vitrectomy Then Cataract Surgery" Under Local-regional Anesthesia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Vitreous Disorder
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomised, double-arms, parallel, open-label study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intraoperative iris hernia occurence
timeFrame: During the combined surgery
Secondary outcomes:
measure: Other intraoperative complications occurence
timeFrame: During the combined surgery
measure: Post-operative complications occurence
timeFrame: At 6 months after the combined surgery
measure: Combined surgery duration in minutes
timeFrame: At the end of the combined surgery
measure: Ocular hypertension occurence
timeFrame: At 1 month, 3 months and 6 months after combined surgery
measure: Combined Surgery-related costs assessment
timeFrame: At the time of the combined surgery.
measure: Visual acuity assessment
timeFrame: At 6 months after combined surgery.
Other outcomes:
Locations:
city: Somain
country: France
facility: Institut Ophtalmique de Somain
Study officials:
References: