Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Performance and Safety of Routine Cataract Surgery With Visiol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04866706
Recruitment Status : Not yet recruiting
First Posted : April 30, 2021
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
TRB Chemedica

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
In this clinical investigation, the performance and safety of routine cataract surgery with VISIOL will be assessed

Condition or disease Intervention/treatment
Following Cataract Surgery Device: Visiol

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Performance and Safety of Routine Cataract Surgery With Visiol
Estimated Study Start Date : November 15, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: Visiol
    VISIOL is a 2.0% (m/v) SH viscoelastic solution used for ocular surgery.
    Other Name: Sodium hyaluronate

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures:
  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;

    1. = Isolated difference in cell size;
    2. = Just noticeable variation in cell size or bumpiness of cell layer;
    3. = Easily detected difference in cell size or bumpiness of cell layer;
    4. = 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

    1. = Peripheral oedema
    2. = Central oedema
    3. = 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

    1. = slightly effective
    2. = moderately effective
    3. = 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

    1. = slight improvement
    2. = moderate improvement
    3. = 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

    1. = slight improvement
    2. = moderate improvement
    3. = 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04866706


Contacts
Layout table for location contacts
Contact: Juree Patarasuwankul, Pharmacy 66817373301 juree.p@trbchemedica.co.th

Sponsors and Collaborators
TRB Chemedica
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: TRB Chemedica
ClinicalTrials.gov Identifier: NCT04866706    
Other Study ID Numbers: SVS18-CT-1901
First Posted: April 30, 2021    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: April 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cataract
Lens Diseases
Eye Diseases
Hyaluronic Acid
Adjuvants, Immunologic
 Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents