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Clinical Study to Compare Visual Performance of Two Trifocal IOLs (PHY1702)

Primary Purpose

Cataract, Lens Opacities, Presbyopia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
IOL implantation experimental
IOL implantation active comparator
Sponsored by
Beaver-Visitec International, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Intraocular Lens, trifocal, hydrophobic, hydrophilic

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Innova Ocular IOA Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IOL implantation experimental

IOL implantation active comparator

Arm Description

hydrophobic, trifocal intraocular lens POD F GF

hydrophilic, trifocal intraocular lens POD F

Outcomes

Primary Outcome Measures

monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.
The primary study end point is to show statistically equal visual acuity outcomes between both study groups. The primary study endpoint parameter is monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014

Secondary Outcome Measures

Manifested refraction - Sphere
The spherical part of the manifested refraction is measured by means of a phoropter. The examination is done according to ISO 11979-7:2014.
Manifested refraction - Cylinder
The cylindrical part of the manifested refraction is measured by means of a phoropter. Amount of cylinder and cylinder axis will be noted. The examination is done according to ISO 11979-7:2014. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE)
Uncorrected Distance Visual Acuity (UDVA)
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly.
Corrected Distance Visual Acuity (CDVA)
CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA)
DCIVA is measured with Radner reading charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Distance Corrected Intermediate Visual Acuity at 63cm (DCIVA)
DCIVA is measured with ETDRS charts placed in 63cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Distance Corrected Near Visual Acuity at 40cm (DCNVA)
DCNVA is measured with Radner reading charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Distance Corrected Near Visual Acuity at 25cm (DCNVA)
DCNVA is measured with Radner reading charts placed in 25cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Halometry
Halometry outcomes, measurement by halos software v1.0
Contrast Sensitivity
Contrast Sensitivity under photopic and mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
Aberrometry - SA
Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: Spherical aberration
Aberrometry - HOA
Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: High Order Aberrations
Aberrometry - Tilt
Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: lens tilt
OQAS II - OSI
Outcomes of OQAS II diagnostic device (Ocular Scatter Index)
OQAS II - MTF
Outcomes of OQAS II diagnostic device (Modular Transfer Function)
OQAS II - Strehl Ratio
Outcomes of OQAS II diagnostic device (Strehl Ratio)
questionnaire
Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified questionnaire VFQ-25 (National Eye Institute) will be used. The maximum score for each question is 100. The scoring and evaluation of the questionnaire will be done according to the official guidelines and manual provided by National Eye Institute

Full Information

First Posted
September 26, 2017
Last Updated
May 5, 2021
Sponsor
Beaver-Visitec International, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03347981
Brief Title
Clinical Study to Compare Visual Performance of Two Trifocal IOLs
Acronym
PHY1702
Official Title
Clinical Study to Compare Visual Performance of Two Trifocal IOLs With Different Material (Hydrophobic and Hydrophilic)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
May 21, 2019 (Actual)
Study Completion Date
May 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beaver-Visitec International, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Lens Opacities, Presbyopia
Keywords
Intraocular Lens, trifocal, hydrophobic, hydrophilic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IOL implantation experimental
Arm Type
Experimental
Arm Description
hydrophobic, trifocal intraocular lens POD F GF
Arm Title
IOL implantation active comparator
Arm Type
Active Comparator
Arm Description
hydrophilic, trifocal intraocular lens POD F
Intervention Type
Device
Intervention Name(s)
IOL implantation experimental
Intervention Description
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
Intervention Type
Device
Intervention Name(s)
IOL implantation active comparator
Intervention Description
Implantation of trifocal IOL POD F consisting of hydrophilic material
Primary Outcome Measure Information:
Title
monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.
Description
The primary study end point is to show statistically equal visual acuity outcomes between both study groups. The primary study endpoint parameter is monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014
Time Frame
3 months postoperative
Secondary Outcome Measure Information:
Title
Manifested refraction - Sphere
Description
The spherical part of the manifested refraction is measured by means of a phoropter. The examination is done according to ISO 11979-7:2014.
Time Frame
3 months postoperative
Title
Manifested refraction - Cylinder
Description
The cylindrical part of the manifested refraction is measured by means of a phoropter. Amount of cylinder and cylinder axis will be noted. The examination is done according to ISO 11979-7:2014. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE)
Time Frame
3 months postoperative
Title
Uncorrected Distance Visual Acuity (UDVA)
Description
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly.
Time Frame
3 months postoperative
Title
Corrected Distance Visual Acuity (CDVA)
Description
CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Time Frame
3 months postoperative
Title
Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA)
Description
DCIVA is measured with Radner reading charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Time Frame
3 months postoperative
Title
Distance Corrected Intermediate Visual Acuity at 63cm (DCIVA)
Description
DCIVA is measured with ETDRS charts placed in 63cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Time Frame
3 months postoperative
Title
Distance Corrected Near Visual Acuity at 40cm (DCNVA)
Description
DCNVA is measured with Radner reading charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Time Frame
3 months postoperative
Title
Distance Corrected Near Visual Acuity at 25cm (DCNVA)
Description
DCNVA is measured with Radner reading charts placed in 25cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Time Frame
3 months postoperative
Title
Halometry
Description
Halometry outcomes, measurement by halos software v1.0
Time Frame
3 months postoperative
Title
Contrast Sensitivity
Description
Contrast Sensitivity under photopic and mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
Time Frame
3 months postoperative
Title
Aberrometry - SA
Description
Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: Spherical aberration
Time Frame
3 months postoperative
Title
Aberrometry - HOA
Description
Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: High Order Aberrations
Time Frame
3 months postoperative
Title
Aberrometry - Tilt
Description
Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: lens tilt
Time Frame
3 months postoperative
Title
OQAS II - OSI
Description
Outcomes of OQAS II diagnostic device (Ocular Scatter Index)
Time Frame
3 months postoperative
Title
OQAS II - MTF
Description
Outcomes of OQAS II diagnostic device (Modular Transfer Function)
Time Frame
3 months postoperative
Title
OQAS II - Strehl Ratio
Description
Outcomes of OQAS II diagnostic device (Strehl Ratio)
Time Frame
3 months postoperative
Title
questionnaire
Description
Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified questionnaire VFQ-25 (National Eye Institute) will be used. The maximum score for each question is 100. The scoring and evaluation of the questionnaire will be done according to the official guidelines and manual provided by National Eye Institute
Time Frame
3 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Poyales Galan, MD
Organizational Affiliation
Innova Ocular IOA Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innova Ocular IOA Madrid
City
Madrid
ZIP/Postal Code
28003
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Study to Compare Visual Performance of Two Trifocal IOLs

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