Clinical trial NCT03347981: Clinical Study to Compare Visual Performance of Two Trifocal IOLs
Official title: Clinical Study to Compare Visual Performance of Two Trifocal IOLs With Different Material (Hydrophobic and Hydrophilic)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lens Opacities
Presbyopia
Keywords: Intraocular Lens
trifocal
hydrophobic
hydrophilic
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-20
Enrollment: 53
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study to compare the clinical outcomes of two trifocal IOLs with different material

Detailed description: This is a prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the hydrophobic IOL FineVision POD F GF or the hydrophilic IOL FineVision Pod F.

The primary and secondary effectiveness data for visual acuity, contrast sensitivity, halometry, aberrometry, questionnaire outcomes and any adverse events will be collected.

Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 3 months. Subjects would have the option for unscheduled visits if required medically.

Primary endpoint data will be collected at the 3 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan.

Eligibility criteria: Inclusion Criteria:

* Cataractous eyes with no comorbidity
* Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent

Exclusion Criteria:

* Irregular astigmatism
* Age of patient \< 50 years
* Regular corneal astigmatism \>1.00 dioptres by an automatic keratometer or biometer or \>1.25 dioptres if the steep axis of cylinder is between 90° and 120° in one or both eyes
* Difficulty for cooperation (distance from their home, general health condition)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
* AMD suspicious eyes (determined by OCT)
* Complicated surgery

Primary outcomes:
measure: monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Manifested refraction - Sphere
timeFrame: 3 months postoperative
measure: Manifested refraction - Cylinder
timeFrame: 3 months postoperative
measure: Uncorrected Distance Visual Acuity (UDVA)
timeFrame: 3 months postoperative
measure: Corrected Distance Visual Acuity (CDVA)
timeFrame: 3 months postoperative
measure: Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA)
timeFrame: 3 months postoperative
measure: Distance Corrected Intermediate Visual Acuity at 63cm (DCIVA)
timeFrame: 3 months postoperative
measure: Distance Corrected Near Visual Acuity at 40cm (DCNVA)
timeFrame: 3 months postoperative
measure: Distance Corrected Near Visual Acuity at 25cm (DCNVA)
timeFrame: 3 months postoperative
measure: Halometry
timeFrame: 3 months postoperative
measure: Contrast Sensitivity
timeFrame: 3 months postoperative
measure: Aberrometry - SA
timeFrame: 3 months postoperative
measure: Aberrometry - HOA
timeFrame: 3 months postoperative
measure: Aberrometry - Tilt
timeFrame: 3 months postoperative
measure: OQAS II - OSI
timeFrame: 3 months postoperative
measure: OQAS II - MTF
timeFrame: 3 months postoperative
measure: OQAS II - Strehl Ratio
timeFrame: 3 months postoperative
measure: questionnaire
timeFrame: 3 months postoperative
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Innova Ocular IOA Madrid
Study officials:
affiliation: Innova Ocular IOA Madrid
name: Francisco Poyales Galan, MD
role: PRINCIPAL_INVESTIGATOR
References: