Performance of a Hydrophilic and a Hydrophobic Intraocular Lens of Similar Design

• ClinicalTrials.gov Identifier: NCT03955796
• Recruitment Status: Withdrawn
• First Posted: May 20, 2019
• Last Update Posted: August 10, 2021
• Sponsor: Prim. Prof. Dr. Oliver Findl, MBA
• Information provided by (Responsible Party): Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

Study Description

Brief Summary:

Comparison of the capsular bag performance of the RayOne Hydrophobic Aspheric with the RayOne Aspheric

Condition or disease	Intervention/treatment	Phase
Cataract	Device: Hydrophobic IOL; Device: Non-hydrophobic IOL	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Capsular Bag Performance of a Hydrophilic and a Hydrophobic Acrylic Intraocular Lens of Similar Design
• Actual Study Start Date: May 9, 2019
• Actual Primary Completion Date: August 3, 2021
• Actual Study Completion Date: August 3, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: RayOne Hydrophobic Aspheric; Patient will receive the hydrophobic IOL during cataract surgery	Device: Hydrophobic IOL; RayOne Hydrophobic Aspheric, hydrophobic IOL
Experimental: RayOne Aspheric; Patient will receive the non-hydrophobic IOL during cataract surgery	Device: Non-hydrophobic IOL; RayOne Aspheric, non-hydrophobic IOL

Outcome Measures

Primary Outcome Measures :

1. Anterior chamber depth (ACD) [ Time Frame: 24 months ]
   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 :

1. Distance visual acuity [ Time Frame: 24 months ]
   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
2. Intraocular pressure [ Time Frame: 24 months ]
   Intraocular pressure will be measured before and after surgery using non-contact-tonometry and differences will be compared between the two differen IOLs

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 105 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

Austria

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Vienna, Austria, 1140

Sponsors and Collaborators

Prim. Prof. Dr. Oliver Findl, MBA

More Information

• Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
• ClinicalTrials.gov Identifier: NCT03955796
• Other Study ID Numbers: Ray hydrophobic
• First Posted: May 20, 2019
• Last Update Posted: August 10, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery:

Cataract, cataract surgery, intraocular lens

Additional relevant MeSH terms:

Cataract; Lens Diseases; Eye Diseases