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In this clinical investigation, the performance and safety of routine cataract surgery with VISIOL will be assessed
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visiol | Device | VISIOL is a 2.0% (m/v) SH viscoelastic solution used for ocular surgery. |
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| 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 |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Over 18 years cataract patients whom investigator routine considered to treat by surgery with Visiol before recruit to study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajavithi Hospital | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41787207 | Derived | Rojananuangnit K, Somkijrungroj T, Hongyok T, Thatsnarong D, Panyayingyong N, Collaud Basset S. Real-World Performance and Safety of VISIOL in Modern Routine Cataract Surgery. Ophthalmol Ther. 2026 Apr;15(4):1389-1405. doi: 10.1007/s40123-026-01345-w. Epub 2026 Mar 5. |
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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;
| 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
| 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
| 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
| 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
| 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 |