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OpenTrials
Completed

NCT Number: NCT04866706

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

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Key information

Conditions

Following Cataract Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rajavithi Hospital

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Visiol

Device

VISIOL is a 2.0% (m/v) SH viscoelastic solution used for ocular surgery.

Other names: Sodium hyaluronate

Primary outcomes

  1. Corneal endothelial cells density in percent

    Time frame: Change from pre-surgery Corneal endothelial cells density at Day 1, Day 7, Day 30, Day 90

    The variation of corneal endothelial cells density (cells/mm2) as compared to baseline (pre-surgery) will be calculated (%)

Other outcomes

  1. Corneal endothelial cells area

    Time frame: Change from pre-surgery Corneal endothelial cells area at Day 1, Day 7, Day 30, Day 90

    The area (µm2) of corneal endothelial cells will be measured using a non-contact specular microscopy.

  2. Corneal endothelial cells density

    Time frame: Change from pre-surgery Corneal endothelial cells density at Day 1, Day 7, Day 30, Day 90

    The density (cells/mm2) of corneal endothelial cells will be measured using a non-contact specular microscopy.

  3. Corneal endothelial cells regularity

    Time frame: Change from pre-surgery Corneal endothelial cells regularity at Day 1, Day 7, Day 30, Day 90

    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.

  4. The presence of keratic precipitates

    Time frame: Change from pre-surgery presence of keratic precipitate at Day 1, Day 7, Day 30, Day 90

    The presence (0 = No, 1 = Yes) of Keratic precipitate will be recorded

  5. A description of keratic precipitates type

    Time frame: Change from pre-surgery a description of keratic precipitates type at Day 1, Day 7, Day 30, Day 90

    A description of keratic precipitates type will be recorded

  6. Central corneal thickness

    Time frame: Change from pre-surgery central corneal thickness at Day 1, Day 7, Day 30, Day 90

    Central corneal thickness (micrometer) will be measured using non-contact specular microscopy

  7. Corneal oedema

    Time frame: Change from pre-surgery corneal oedema at Day 1, Day 7, Day 30, Day 90

    Corneal oedema grading will be assessed using a specular microscopy. Gradings will be referred to location of oedema

    • = Peripheral oedema
    • = Central oedema
    • = Generalised oedema

  8. Intra-ocular pressure

    Time frame: Change from pre-surgery intra-ocular pressure at Day 0 (surgery day), Day 1, Day 7, Day 30, Day 90

    Intra-ocular pressure (mmHg) will be evaluated using a Goldmann applanation tonometry

  9. Incidence of intra-ocular pressure peak

    Time frame: Change from pre-surgery intra-ocular pressure peaks at Day 0 (surgery day), Day 1, Day 7, Day 30, Day 90

    The incidence of intra-ocular pressure peaks (≥ 30 mmHg) will be recorded

  10. Anterior chamber inflammation cell

    Time frame: Change from pre-surgery anterior chamber inflammation cell at Day 1, Day 7, Day 30, Day 90

    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

  11. Anterior chamber inflammation flare

    Time frame: Change from pre-surgery anterior chamber inflammation flare at Day 1, Day 7, Day 30, Day 90

    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)

  12. Best corrected visual acuity (BCVA)

    Time frame: Change from pre-surgery BCVA at Day 1, Day 7, Day 30, Day 90

    BCVA will be evaluated using standard ETDRS logMAR chart

  13. Intra-surgery information for duration of intervention

    Time frame: During Surgery (Day 0)

    duration of intervention (min)

  14. Intra-surgery information for use of finger grip

    Time frame: During Surgery (Day 0)

    Use of finger grip (yes or no)

  15. Intra-surgery information for time needed to remove VISIOL

    Time frame: During Surgery (Day 0)

    Time needed to remove VISIOL (min) counted from the time when intra-ocular lens was inserted until when the aspiration tip is removed

  16. Intra-surgery information for volume of VISIOL used

    Time frame: During Surgery (Day 0)

    Total volume of VISIOL used (mL)

  17. Intra-surgery information for material of intra-ocular lens used

    Time frame: During Surgery (Day 0)

    Material of intra-ocular lens used (acrylic or silicone)

  18. Intra-surgery information for power of intra-ocular lens used

    Time frame: During Surgery (Day 0)

    Power (diopters) of intra-ocular lens used

  19. Intra-surgery information for incision size

    Time frame: During Surgery (Day 0)

    Incision size (mm)

  20. Intra-surgery information for energetic parameter power or energy

    Time frame: During Surgery (Day 0)

    Power or energy (% or mJ) during phacoemulsification and photolysis

  21. Intra-surgery information for time of phacoemulsification

    Time frame: During Surgery (Day 0)

    Time (min) during phacoemulsification

  22. Intra-surgery information for vacuum

    Time frame: During Surgery (Day 0)

    Vacuum (mmHg) during phacoemulsification

  23. Investigator's subjective judgement

    Time frame: During Surgery (Day 0)

    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

  24. Global evaluation of the performance by the investigator

    Time frame: Surgery day (Day 0) and Day 90

    Global evaluation of the performance of cataract surgery with VISIOL by the investigator 0 = no improvement

    • = slight improvement
    • = moderate improvement
    • = great improvement

  25. Global evaluation of the performance by the patient

    Time frame: Surgery day (Day 0) and Day 90

    Global evaluation of the performance of cataract surgery with VISIOL by the patient 0 = no improvement

    • = slight improvement
    • = moderate improvement
    • = great improvement

  26. Adverse events (AE)

    Time frame: Pre-surgery, Surgery day (Day 0), Day 1, Day 7, Day 30, Day 90

    including their incidence, intensity, seriousness, expectedness and causal relationship with the use of investigational device or study procedure

Sponsors and collaborators

Lead sponsor

TRB Chemedica

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 30, 2021
Registry last updated
Nov 22, 2023

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.