The ADVISE Study: Advanced Visualization In Corneal Surgery Evaluation
Condition: Fuchs Dystrophy; Endothelial Corneal Dystrophy; Bullous Keratopathy; Vision Disorders
MeSH terms: Vision Disorders; Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy
Study type: Interventional

Summary: 
      Rationale: Intra-operative optical coherence tomography (iOCT) is a new technology that
      incorporates advanced imaging techniques in the ophthalmic operating theatre. This allows
      surgeons to visualize tissues in a way previously impossible We conceptualized an iOCT-guided
      surgical protocol for the treatment of endothelial cell dysfunction, that refrains from the
      current practice of over-pressurizing the eye at the end of surgery.

      Objective: The aim of this study is to assess the clinical value of intraoperative OCT (iOCT)
      for Descemet Membrane Endothelial Keratoplasty (DMEK) by comparing an iOCT-optimized surgical
      protocol with current practice, where the eye is over-pressurized for a set period of time,
      in terms of surgical efficiency, clinical outcomes, and adverse events.

      Study design: International multicentre non-inferiority randomized clinical trial Study
      population: Patients scheduled for posterior lamellar corneal surgery for endothelial cell
      dysfunction above the age of 18 years.

      Intervention: Both groups will undergo Descemet Membrane Endothelial Keratoplasty. Patients
      will be randomized for either the iOCT optimized surgical protocol or current standard
      surgical protocol using 8 minutes of overpressure to facilitate graft adherence. Both groups
      will be evaluated with iOCT at the end of surgery.

      Main study parameters/endpoints:

      The main study parameter is the rate of adverse events (particularly graft dislocations).
      Secondary parameters/endpoints are surgical time, the recovery of visual acuity and
      endothelial graft quality at 3 and 6 months follow-up, and a detailed evaluation of the
      extent/duration of surgical tissue manipulations.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: The use of iOCT during surgery does not entail additional risk to the patient.
      Participants to this study will adhere to the standard of care after corneal transplant
      surgery. In addition, they will receive study specific measurements and questionnaires. The
      additional measurements and questionnaires will be combined with regular follow up moments.
    


Intervention name(s): intraoperative optical coherence tomography (iOCT)
Intervention type(s): Device
Intervention description(s): The OCT technology is fully integrated in a conventional ophthalmic surgical microscope (Zeiss LUMERA 700 platform). The OCT consists of A-scans (length/thickness) and B-scans (X-Y plane) to create the three dimensional image. Alternatively C-scans (3D cube scans) are available. All scans are non-invasive. The surgeon can continue surgery whilst using the iOCT and view a live image projected in the binocular or on the external screen and the video stream can be recorded as well.
The iOCT features are controlled using the foot paddle and the images are recorded on device. Investigations will be performed in a standardized matter: iOCT imagery and cube-scans after graft insertion, air injection, and the end of surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The design of the study is a prospective, international, multicenter, non-inferiority, randomized controlled interventional clinical trial to compare the outcomes after posterior lamellar surgery with an iOCT optimized surgical protocol, and current practice, where the eye is over-pressurized for a set period of time. These groups will be labelled iOCT optimized protocol (iOCT-p) and current practice protocol (CP-p). Eligible patients will be assigned to either one of the groups. The study will be conducted simultaneously at the University Medical Center Utrecht (UMCU), Maastricht University Medical Center (MUMC) and the University Hospitals Leuven (UZL, Belgium). The inclusion, preoperative and postoperative measurements and questionnaires will take place at the Ophthalmology department of the site were the surgery was conducted. The research activities will be coordinated by the UMCU.
Masking: Single (Participant)
Primary purpose: Diagnostic