Performance and Safety of Routine Cataract Surgery With Visiol

In this clinical investigation, the performance and safety of routine cataract surgery with VISIOL will be assessed

Study Overview

• Status: Completed
• Conditions: Following Cataract Surgery
• Intervention / Treatment: Device: Visiol

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Over 18 years cataract patients whom investigator routine considered to treat by surgery with Visiol before recruit to study

Description

Inclusion Criteria:

• Male or female aged 18 years and older;
• Candidate for cataract surgery via phacoemulsification;
• Ophthalmic surgeon's recommendation to use VISIOL prior to recruitment;
• Eligible for the use of VISIOL as indicated in the instructions for use;
• Written informed consent.

Exclusion Criteria:

• Known allergy or hypersensitivity to any of VISIOL components;
• Known pregnancy or breast feeding;
• Participation in any other clinical research study within the last 90 days;
• Patients with legally restricted autonomy, freedom of decision and action (e.g. those with measure of custody or judicial protection);
• Incapacity to understand the informed consent and/or to comply with the Clinical Investigation Plan (CIP), per investigator's appreciation.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal endothelial cells density in percent	The variation of corneal endothelial cells density (cells/mm2) as compared to baseline (pre-surgery) will be calculated (%)	Change from pre-surgery Corneal endothelial cells density at Day 1, Day 7, Day 30, Day 90

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal endothelial cells area	The area (µm2) of corneal endothelial cells will be measured using a non-contact specular microscopy.	Change from pre-surgery Corneal endothelial cells area at Day 1, Day 7, Day 30, Day 90
Corneal endothelial cells density	The density (cells/mm2) of corneal endothelial cells will be measured using a non-contact specular microscopy.	Change from pre-surgery Corneal endothelial cells density at Day 1, Day 7, Day 30, Day 90
Corneal endothelial cells regularity	The regularity (variation of size) of corneal endothelial cells will be measured using a non-contact specular microscopy. In particular, the endothelial regularity will be assessed using the following classification described in ISO 11980:2012:37 0 = Regular endothelial mosaic; = Isolated difference in cell size;; = Just noticeable variation in cell size or bumpiness of cell layer;; = Easily detected difference in cell size or bumpiness of cell layer;; = Noticeable cell layer bumpiness and loss of definition of cell borders.	Change from pre-surgery Corneal endothelial cells regularity at Day 1, Day 7, Day 30, Day 90
The presence of keratic precipitates	The presence (0 = No, 1 = Yes) of Keratic precipitate will be recorded	Change from pre-surgery presence of keratic precipitate at Day 1, Day 7, Day 30, Day 90
A description of keratic precipitates type	A description of keratic precipitates type will be recorded	Change from pre-surgery a description of keratic precipitates type at Day 1, Day 7, Day 30, Day 90
Central corneal thickness	Central corneal thickness (micrometer) will be measured using non-contact specular microscopy	Change from pre-surgery central corneal thickness at Day 1, Day 7, Day 30, Day 90
Corneal oedema	Corneal oedema grading will be assessed using a specular microscopy. Gradings will be referred to location of oedema; = Peripheral oedema; = Central oedema; = Generalised oedema	Change from pre-surgery corneal oedema at Day 1, Day 7, Day 30, Day 90
Intra-ocular pressure	Intra-ocular pressure (mmHg) will be evaluated using a Goldmann applanation tonometry	Change from pre-surgery intra-ocular pressure at Day 0 (surgery day), Day 1, Day 7, Day 30, Day 90
Incidence of intra-ocular pressure peak	The incidence of intra-ocular pressure peaks (≥ 30 mmHg) will be recorded	Change from pre-surgery intra-ocular pressure peaks at Day 0 (surgery day), Day 1, Day 7, Day 30, Day 90
Anterior chamber inflammation cell	Anterior chamber inflammation will be assessed using slit lamp biomicroscopy (1 mm slit beam). It will be classified based on SUN grading Grade 0 = < 1 cell in field Grade 0.5 = 1-5 cells in field Grade 1 = 6-15 cells in field Grade 2 = 16-25 cells in field Grade 3 = 26-50 cells in field Grade 4 = over 50 cells in field	Change from pre-surgery anterior chamber inflammation cell at Day 1, Day 7, Day 30, Day 90
Anterior chamber inflammation flare	Anterior chamber inflammation will be assessed using slit lamp biomicroscopy (1 mm slit beam). It will be classified based on SUN grading Grade 0 = no flare Grade 1 = faint Grade 2 = moderate (iris/ lens details clear) Grade 3 = marked (iris/ lens details hazy) Grade 4 = Intense (fibrin/ plastic aqueous)	Change from pre-surgery anterior chamber inflammation flare at Day 1, Day 7, Day 30, Day 90
Best corrected visual acuity (BCVA)	BCVA will be evaluated using standard ETDRS logMAR chart	Change from pre-surgery BCVA at Day 1, Day 7, Day 30, Day 90
Intra-surgery information for duration of intervention	duration of intervention (min)	During Surgery (Day 0)
Intra-surgery information for use of finger grip	Use of finger grip (yes or no)	During Surgery (Day 0)
Intra-surgery information for time needed to remove VISIOL	Time needed to remove VISIOL (min) counted from the time when intra-ocular lens was inserted until when the aspiration tip is removed	During Surgery (Day 0)
Intra-surgery information for volume of VISIOL used	Total volume of VISIOL used (mL)	During Surgery (Day 0)
Intra-surgery information for material of intra-ocular lens used	Material of intra-ocular lens used (acrylic or silicone)	During Surgery (Day 0)
Intra-surgery information for power of intra-ocular lens used	Power (diopters) of intra-ocular lens used	During Surgery (Day 0)
Intra-surgery information for incision size	Incision size (mm)	During Surgery (Day 0)
Intra-surgery information for energetic parameter power or energy	Power or energy (% or mJ) during phacoemulsification and photolysis	During Surgery (Day 0)
Intra-surgery information for time of phacoemulsification	Time (min) during phacoemulsification	During Surgery (Day 0)
Intra-surgery information for vacuum	Vacuum (mmHg) during phacoemulsification	During Surgery (Day 0)
Investigator's subjective judgement	using a 4 point grading scale: ease of VISIOL injection, maintenance of the anterior chamber depth during the capsulorhexis and IOL implantation, ability to remain in the anterior chamber during phacoemulsification and photolysis, clarity of the substance, ease of capsulorhexis, ease of IOL implementation, ease of VISIOL removal and global impression on the product performance during the surgery. Grading scale will be assessed 0 = Not effective; = slightly effective; = moderately effective; = very effective	During Surgery (Day 0)
Global evaluation of the performance by the investigator	Global evaluation of the performance of cataract surgery with VISIOL by the investigator 0 = no improvement; = slight improvement; = moderate improvement; = great improvement	Surgery day (Day 0) and Day 90
Global evaluation of the performance by the patient	Global evaluation of the performance of cataract surgery with VISIOL by the patient 0 = no improvement; = slight improvement; = moderate improvement; = great improvement	Surgery day (Day 0) and Day 90
Adverse events (AE)	including their incidence, intensity, seriousness, expectedness and causal relationship with the use of investigational device or study procedure	Pre-surgery, Surgery day (Day 0), Day 1, Day 7, Day 30, Day 90

Collaborators and Investigators

• Sponsor: TRB Chemedica

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2022
• Primary Completion (Actual): December 9, 2022
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: April 18, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: SVS18-CT-1901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No