The ADVISE Study: Advanced Visualization In Corneal Surgery Evaluation

Vision Disorders Clinical Trial

— ADVISE  

Official title:

The ADVISE Study: Advanced Visualization In Corneal Surgery Evaluation Intra-operative Optical Coherence Tomography in Posterior Lamellar Keratoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03763721
• Other study ID #: NL64392.041.17
• Status: Completed
• Phase: N/A
• Start date: November 13, 2018
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2022
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 1, 2022
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bullous Keratopathy
• Corneal Dystrophies, Hereditary
• Endothelial Corneal Dystrophy
• Fuchs Dystrophy
• Fuchs' Endothelial Dystrophy
• Vision Disorders

Intervention

Device:
• intraoperative optical coherence tomography (iOCT)
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.

Locations

Country	Name	City	State
Belgium	Universiteitsziekenhuis Leuven	Leuven
Netherlands	Maastricht University Hospital	Maastricht
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (4)

Lead Sponsor	Collaborator
UMC Utrecht	Carl Zeiss Surgical GmbH, Maastricht University Medical Center, Universitaire Ziekenhuizen KU Leuven

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of the most relevant post-operative surgical complications	the number of patients that develop adverse events relating to lamellar corneal surgery, specifically graft detachments that necessitate a surgical intervention, early graft failures that lead to intractable corneal edema, or induced iatrogenic acute glaucoma	within 6 weeks post-operatively
Secondary	Surgical time	times are recorded at entry of the OR, start time of the surgery, actual first incision, timepoint for injection of gas, duration of gas, closing time and departure time of the OR. Out of these both skin-to-skin and overall time in surgery can be calculated (i.e. gross/net)	during surgery
Secondary	Best-corrected visual acuity	Visual acuity is assessed using an ETDRS (Early Treatment Diabetic Retinopathy Study Chart) visual acuity chart with a spectacle correction. Visual acuity measurement ranges from light perception, hand movements, finger counting, 0.05 till 1.0. (US equivalent 20/20)	3 and 6 months follow-up
Secondary	Graft endothelial cell densities	The quality of the graft is based on the amount and viability of endothelial cells. These will be measured (number of cells/mm2, variation in size (variation coefficient), hexagonality-coefficient) with in vivo specular microscopy.	3 and 6 months follow-up
Secondary	Surgical manipulations	the recorded videos will be reviewed and scored considering the amount of surgical manipulations, the duration of all steps of the procedure, and the use of iOCT. All according to a study specific standard operating procedure	during surgery