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Clinical Trials/NCT03688425
NCT03688425CompletedNot Applicable

Clinical Study to Compare Clinical Outcomes of Trifocal IOLs FineVision POD L GF and FineVision POD F GF After Bilateral Implantation in Asian Eyes

Beaver-Visitec International, Inc.2 sites in 1 country58 target enrollmentStarted: October 9, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
58
Locations
2
Primary Endpoint
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions.

Study Overview

Brief Summary

Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs differing in the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). Implantation of the IOLs is bilaterally.

Detailed Description

This is a prospective, randomised, controlled, single-surgeon, single-center clinical 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 L GF or the hydrophobic IOL FineVision POD F GF (both lenses: (PhysIOL, Liège, Belgium).

The devices under investigation (FineVision POD L GF and POD F GF) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. Both consist of the same hydrophobic material. The main difference between the lenses is the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically.

Primary and secondary endpoint data will be collected at the 6 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Cataractous eyes with no comorbidity
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • Signed informed consent

Exclusion Criteria

  • Age of patient <40 years
  • Irregular astigmatism
  • Regular corneal astigmatism >0.75 dioptres by an automatic keratometer or biometer or >1.0 dioptres if the steep axis of cylinder is between 90° and 120°
  • 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)

Outcomes

Primary Outcomes

monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions.

Time Frame: 3 months postoperative

No statistically significant difference between the two study groups on monocular CDVA at 3 months follow up visit. A significance level of 0.05 or lower (p \< 0.05) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014.

Secondary Outcomes

  • Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions(6 months postoperative)
  • Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under photopic light conditions(3 months postoperative)
  • Distance Corrected Near Visual Acuity at 35cm (DCNVA) under mesopic light conditions(6 months postoperative)
  • Uncorrected Near Visual Acuity at 35cm (UNVA) under photopic light conditions(3 months postoperative)
  • Manifested refraction(3 months postoperative)
  • Corrected Distance Visual Acuity (CDVA) under mesopic light conditions(6 months postoperative)
  • Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions(3 months postoperative)
  • Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under photopic light conditions(3 months postoperative)
  • Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under mesopic light conditions(6 months postoperative)
  • Distance Corrected Near Visual Acuity at 35cm (DCNVA) under photopic light conditions(3 months postoperative)
  • Aberrometry(3 months postoperative)
  • Questionnaire VFQ-25 (National Eye Institute)(3 months postoperative)
  • Corrected Distance Visual Acuity (CDVA) under photopic light conditions(3 months postoperative)
  • Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under mesopic light conditions(6 months postoperative)
  • Uncorrected Near Visual Acuity at 35cm (UNVA) under mesopic light conditions(6 months postoperative)
  • Contrast Sensitivity(3 months postoperative)
  • AcuTarget diagnostic device(3 months postoperative)
  • Defocus Curve monocular(1 month postoperative)
  • Defocus Curve binocular(3 months postoperative)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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