NCT03955796

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2021

Completed
Last Updated

August 10, 2021

Status Verified

August 1, 2021

Enrollment Period

2.2 years

First QC Date

May 16, 2019

Last Update Submit

August 3, 2021

Conditions

Cataract

Keywords

Cataract, cataract surgery, intraocular lens

Outcome Measures

Primary Outcomes (1)

  • 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

    24 months

Secondary Outcomes (2)

  • Distance visual acuity

    24 months

  • Intraocular pressure

    24 months

Study Arms (2)

RayOne Hydrophobic Aspheric

EXPERIMENTAL

Patient will receive the hydrophobic IOL during cataract surgery

Device: Hydrophobic IOL

RayOne Aspheric

EXPERIMENTAL

Patient will receive the non-hydrophobic IOL during cataract surgery

Device: Non-hydrophobic IOL

Interventions

Hydrophobic IOLDEVICE

RayOne Hydrophobic Aspheric, hydrophobic IOL

RayOne Hydrophobic Aspheric
Non-hydrophobic IOLDEVICE

RayOne Aspheric, non-hydrophobic IOL

RayOne Aspheric

Eligibility Criteria

Age21 Years - 105 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 20, 2019

Study Start

May 9, 2019

Primary Completion

August 3, 2021

Study Completion

August 3, 2021

Last Updated

August 10, 2021

Record last verified: 2021-08

Locations

AU(1)