Clinical trial NCT04866706: Performance and Safety of Routine Cataract Surgery With Visiol
Official title: Performance and Safety of Routine Cataract Surgery With Visiol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Following Cataract Surgery
Lead sponsor: TRB Chemedica
Sponsor class: INDUSTRY
First posted: 2021-04-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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


Eligibility 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.

Primary outcomes:
measure: Corneal endothelial cells density in percent
timeFrame: Change from pre-surgery Corneal endothelial cells density at Day 1, Day 7, Day 30, Day 90
Secondary outcomes:
Other outcomes:
measure: Corneal endothelial cells area
timeFrame: Change from pre-surgery Corneal endothelial cells area at Day 1, Day 7, Day 30, Day 90
measure: Corneal endothelial cells density
timeFrame: Change from pre-surgery Corneal endothelial cells density at Day 1, Day 7, Day 30, Day 90
measure: Corneal endothelial cells regularity
timeFrame: Change from pre-surgery Corneal endothelial cells regularity at Day 1, Day 7, Day 30, Day 90
measure: The presence of keratic precipitates
timeFrame: Change from pre-surgery presence of keratic precipitate at Day 1, Day 7, Day 30, Day 90
measure: A description of keratic precipitates type
timeFrame: Change from pre-surgery a description of keratic precipitates type at Day 1, Day 7, Day 30, Day 90
measure: Central corneal thickness
timeFrame: Change from pre-surgery central corneal thickness at Day 1, Day 7, Day 30, Day 90
measure: Corneal oedema
timeFrame: Change from pre-surgery corneal oedema at Day 1, Day 7, Day 30, Day 90
measure: Intra-ocular pressure
timeFrame: Change from pre-surgery intra-ocular pressure at Day 0 (surgery day), Day 1, Day 7, Day 30, Day 90
measure: Incidence of intra-ocular pressure peak
timeFrame: Change from pre-surgery intra-ocular pressure peaks at Day 0 (surgery day), Day 1, Day 7, Day 30, Day 90
measure: Anterior chamber inflammation cell
timeFrame: Change from pre-surgery anterior chamber inflammation cell at Day 1, Day 7, Day 30, Day 90
measure: Anterior chamber inflammation flare
timeFrame: Change from pre-surgery anterior chamber inflammation flare at Day 1, Day 7, Day 30, Day 90
measure: Best corrected visual acuity (BCVA)
timeFrame: Change from pre-surgery BCVA at Day 1, Day 7, Day 30, Day 90
measure: Intra-surgery information for duration of intervention
timeFrame: During Surgery (Day 0)
measure: Intra-surgery information for use of finger grip
timeFrame: During Surgery (Day 0)
measure: Intra-surgery information for time needed to remove VISIOL
timeFrame: During Surgery (Day 0)
measure: Intra-surgery information for volume of VISIOL used
timeFrame: During Surgery (Day 0)
measure: Intra-surgery information for material of intra-ocular lens used
timeFrame: During Surgery (Day 0)
measure: Intra-surgery information for power of intra-ocular lens used
timeFrame: During Surgery (Day 0)
measure: Intra-surgery information for incision size
timeFrame: During Surgery (Day 0)
measure: Intra-surgery information for energetic parameter power or energy
timeFrame: During Surgery (Day 0)
measure: Intra-surgery information for time of phacoemulsification
timeFrame: During Surgery (Day 0)
measure: Intra-surgery information for vacuum
timeFrame: During Surgery (Day 0)
measure: Investigator's subjective judgement
timeFrame: During Surgery (Day 0)
measure: Global evaluation of the performance by the investigator
timeFrame: Surgery day (Day 0) and Day 90
measure: Global evaluation of the performance by the patient
timeFrame: Surgery day (Day 0) and Day 90
measure: Adverse events (AE)
timeFrame: Pre-surgery, Surgery day (Day 0), Day 1, Day 7, Day 30, Day 90
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References: