Performance and Safety of Routine Cataract Surgery With Visiol

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• Cataract 1,701

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 100 is above the median of 81 across 484 observational studies indexed under Cataract.

Lead sponsor

TRB Chemedica is the lead sponsor of 7 studies on the registry; none are open to participants now.

Study population

Interventions

• DeviceVisiol

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

  Also known as: Sodium hyaluronate

Primary outcomes

1. Corneal endothelial cells density in percent

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

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

Other outcomes

1. Corneal endothelial cells area

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

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

2. Corneal endothelial cells density

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

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

3. 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; 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.

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

4. The presence of keratic precipitates

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

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

5. A description of keratic precipitates type

   A description of keratic precipitates type will be recorded

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

6. Central corneal thickness

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

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

7. Corneal oedema

   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

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

8. Intra-ocular pressure

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

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

9. Incidence of intra-ocular pressure peak

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

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

10. 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

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

11. 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)

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

12. Best corrected visual acuity (BCVA)

    BCVA will be evaluated using standard ETDRS logMAR chart

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

13. Intra-surgery information for duration of intervention

    duration of intervention (min)

    Time frame: During Surgery (Day 0)

14. Intra-surgery information for use of finger grip

    Use of finger grip (yes or no)

    Time frame: During Surgery (Day 0)

15. 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

    Time frame: During Surgery (Day 0)

16. Intra-surgery information for volume of VISIOL used

    Total volume of VISIOL used (mL)

    Time frame: During Surgery (Day 0)

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

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

    Time frame: During Surgery (Day 0)

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

    Power (diopters) of intra-ocular lens used

    Time frame: During Surgery (Day 0)

19. Intra-surgery information for incision size

    Incision size (mm)

    Time frame: During Surgery (Day 0)

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

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

    Time frame: During Surgery (Day 0)

21. Intra-surgery information for time of phacoemulsification

    Time (min) during phacoemulsification

    Time frame: During Surgery (Day 0)

22. Intra-surgery information for vacuum

    Vacuum (mmHg) during phacoemulsification

    Time frame: During Surgery (Day 0)

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

    Time frame: During Surgery (Day 0)

24. Global evaluation of the performance by the investigator

    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

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

25. Global evaluation of the performance by the patient

    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

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

26. Adverse events (AE)

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

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