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Completed

NCT Number: NCT05583331

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Vitreous Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Ophtalmique de Somain

Somain, 59490, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cataract surgery

Procedure

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

Vitrectomy

Procedure

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

Primary outcomes

  1. Intraoperative iris hernia occurence

    Time frame: During the combined surgery

Secondary outcomes

  1. Other intraoperative complications occurence

    Time frame: During the combined surgery

  2. Post-operative complications occurence

    Time frame: At 6 months after the combined surgery

  3. Combined surgery duration in minutes

    Time frame: At the end of the combined surgery

  4. Ocular hypertension occurence

    Time frame: At 1 month, 3 months and 6 months after combined surgery

  5. Combined Surgery-related costs assessment

    Time frame: At the time of the combined surgery.

  6. Visual acuity assessment

    Time frame: At 6 months after combined surgery.

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study 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

Acronym: VICAR

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 17, 2022
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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