Clinical trial NCT03763721: The ADVISE Study: Advanced Visualization In Corneal Surgery Evaluation
Official title: The ADVISE Study: Advanced Visualization In Corneal Surgery Evaluation Intra-operative Optical Coherence Tomography in Posterior Lamellar Keratoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fuchs Dystrophy
Endothelial Corneal Dystrophy
Bullous Keratopathy
Vision Disorders
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
name: Universitaire Ziekenhuizen KU Leuven
name: Carl Zeiss Surgical GmbH
First posted: 2018-12-04
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Irreversible corneal decompensation caused by Fuchs corneal endothelial dystrophy or pseudophakic bullous keratopathy
* Eligible for posterior lamellar keratoplasty, specifically Descemet Membrane Endothelial Keratoplasty (DMEK)

Exclusion Criteria:

* Any ocular co-morbidity other than cataract, mild dry eye disease, ocular hypertension, simple primary open angle glaucoma, and mild age-related macular degeneration
* Prior corneal transplant surgery
* Human leukocyte antigen (HLA) matched keratoplasty
* Any disability that will interfere with performing or understanding the procedures and questionnaire fulfilment except if it is temporary of nature.
* Combined phaco-emulsification-DMEK surgery (triple procedure)

Primary outcomes:
measure: rate of the most relevant post-operative surgical complications
timeFrame: within 6 weeks post-operatively
Secondary outcomes:
measure: Surgical time
timeFrame: during surgery
measure: Best-corrected visual acuity
timeFrame: 3 and 6 months follow-up
measure: Graft endothelial cell densities
timeFrame: 3 and 6 months follow-up
measure: Surgical manipulations
timeFrame: during surgery
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universiteitsziekenhuis Leuven
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References: