Performance of a Hydrophilic and a Hydrophobic Intraocular Lens of Similar Design
Primary Purpose
Cataract
Status
Withdrawn
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Hydrophobic IOL
Non-hydrophobic IOL
Sponsored by

About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract, cataract surgery, intraocular lens
Eligibility Criteria
Inclusion Criteria:
- Age-related bilateral cataract
- Age 21 or older
- Visual acuity > 0.05
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Written informed consent prior to surgery
Exclusion Criteria:
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS), cornea pathologies
- Previous ocular surgery or trauma
- Pregnancy (pregnancy test will be taken in women of reproductive age)
Sites / Locations
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
RayOne Hydrophobic Aspheric
RayOne Aspheric
Arm Description
Patient will receive the hydrophobic IOL during cataract surgery
Patient will receive the non-hydrophobic IOL during cataract surgery
Outcomes
Primary Outcome Measures
Anterior chamber depth (ACD)
The change in anterior chamber depth (ACD) before and after surgery will be measured using the IOL Master 700 and compared between the two different IOLs
Secondary Outcome Measures
Distance visual acuity
Uncorrected and corrected distance visual acuity will be determined using ETDRS-charts in a distance of 4 meters and differences in refraction will be compared between the two IOLs
Intraocular pressure
Intraocular pressure will be measured before and after surgery using non-contact-tonometry and differences will be compared between the two differen IOLs
Full Information
NCT ID
NCT03955796
First Posted
May 16, 2019
Last Updated
August 3, 2021
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
1. Study Identification
Unique Protocol Identification Number
NCT03955796
Brief Title
Performance of a Hydrophilic and a Hydrophobic Intraocular Lens of Similar Design
Official Title
Capsular Bag Performance of a Hydrophilic and a Hydrophobic Acrylic Intraocular Lens of Similar Design
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Changes will be made in the design of one of the study IOLs
Study Start Date
May 9, 2019 (Actual)
Primary Completion Date
August 3, 2021 (Actual)
Study Completion Date
August 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Comparison of the capsular bag performance of the RayOne Hydrophobic Aspheric with the RayOne Aspheric
Detailed Description
Cataract surgery is nowadays considered a safe surgery with a short rehabilitation time for the patients. Two main problems arising post-surgically are the predictability and stability of the implanted intraocular lens (IOL) in the capsular back and the formation of posterior capsule opacification (PCO). The performance of the IOL in the capsular bag influences the anterior chamber depth (ACD), tilt and decentration of the IOL, as well as formation of PCO. The main source of error for calculation of IOL power is an inaccurate prediction of the post-surgical ACD resulting in short- or farsightedness. Furthermore, capsular fibrosis and phimosis can also lead to tilt and decentration of the intraocular lens.
PCO is one of the most frequent long-term complications after cataract surgery, occuring in about 12% after 1 year, in 21% after 3 years, and in 28% after 5 years post-surgically. PCO arises when lens epithelial cells (LECs) migrate and proliferate, growing in between the IOL and the posterior capsule, leading to decreased visual acuity.
Material and design of the IOL may have an effect on the formation of PCO. It is suggested that 360° square edge design and hydrophobic material of the IOL may help in the prevention of PCO.
Hence, the aim of this study is to evaluate the capsular bag performance of monofocal IOLs with different materials but similar design and their influence on PCO formation.
100 eyes of 50 patients will be included into this study. After randomization one eye is implanted with the hydrophilic IOL, whereas the other eye gets the aspherical IOL. Follow-up visits will be 1 - 2 hours and 1 week after the surgery, as well as 6 months, 12 months, and 24 months post-surgically. During this visit a slit lamp examination, measurement of the intraocular pressure, visual acuity assessment, biometrical measurements of the eye, retroillumination photography and analysis of tilt and decentration of the IOL using the purkinjemeter will be performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, cataract surgery, intraocular lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RayOne Hydrophobic Aspheric
Arm Type
Experimental
Arm Description
Patient will receive the hydrophobic IOL during cataract surgery
Arm Title
RayOne Aspheric
Arm Type
Experimental
Arm Description
Patient will receive the non-hydrophobic IOL during cataract surgery
Intervention Type
Device
Intervention Name(s)
Hydrophobic IOL
Intervention Description
RayOne Hydrophobic Aspheric, hydrophobic IOL
Intervention Type
Device
Intervention Name(s)
Non-hydrophobic IOL
Intervention Description
RayOne Aspheric, non-hydrophobic IOL
Primary Outcome Measure Information:
Title
Anterior chamber depth (ACD)
Description
The change in anterior chamber depth (ACD) before and after surgery will be measured using the IOL Master 700 and compared between the two different IOLs
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Distance visual acuity
Description
Uncorrected and corrected distance visual acuity will be determined using ETDRS-charts in a distance of 4 meters and differences in refraction will be compared between the two IOLs
Time Frame
24 months
Title
Intraocular pressure
Description
Intraocular pressure will be measured before and after surgery using non-contact-tonometry and differences will be compared between the two differen IOLs
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age-related bilateral cataract
Age 21 or older
Visual acuity > 0.05
Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Written informed consent prior to surgery
Exclusion Criteria:
Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS), cornea pathologies
Previous ocular surgery or trauma
Pregnancy (pregnancy test will be taken in women of reproductive age)
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
City
Vienna
ZIP/Postal Code
1140
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Performance of a Hydrophilic and a Hydrophobic Intraocular Lens of Similar Design
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