NCT01268540

Brief Summary

The purpose of this multi-center clinical trial is to determine the safety and efficacy of the HSO Toric IOLs for the correction of aphakia and reduction of pre-existing refractive astigmatism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
235

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

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

December 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2015

Enrollment Period

3.5 years

First QC Date

December 29, 2010

Last Update Submit

February 4, 2015

Conditions

AphakiaCataract

Keywords

intraocular lensIOLcataractrefractive astigmatismAsphericToricHoyaSurgicalOpticsvisual acuity

Outcome Measures

Primary Outcomes (1)

  • percent reduction of absolute cylinder

    up to 14 months

Secondary Outcomes (1)

  • Lens rotation or misalignment and patient satisfaction

    up to 14 months

Study Arms (4)

NHT15

EXPERIMENTAL

Aspheric Toric Intraocular Lens Models NHT15

Device: NHT15, NHT30, & NHT53

FY-60AD

ACTIVE COMPARATOR

Aspheric Non-toric Intraocular Lens: Model FY-60AD

Device: FY-60AD

NHT30

EXPERIMENTAL

Aspheric Toric Intraocular Lens Model NHT30

Device: NHT15, NHT30, & NHT53

NHT53

EXPERIMENTAL

Aspheric Toric Intraocular Lens Models NHT53

Device: NHT15, NHT30, & NHT53

Interventions

FY-60ADDEVICE

Phacoemulsification cataract extraction followed by implantation of an aspheric non-toric intraocular lens: Model FY-60AD.

FY-60AD
NHT15, NHT30, & NHT53DEVICE

Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.

NHT15NHT30NHT53

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated
  • Have at least one eye that meets the ranges of pre-operative corneal cylinder as specified by this study's guidelines, i.e. corneal cylinder of at least 1.0 D (after accounting for changes in corneal cylinder due to the incision)
  • Have potential Best Corrected Visual Acuity of 20/30 or better after implantation of a study lens
  • Have clear intraocular media other than cataract
  • Have preoperative Best Corrected Visual Acuity equal to 20/40 or worse, with or without a glare source

You may not qualify if:

  • Have atonic pupils or physiologically small pupils in either eye (unable to dilate to at least 4 mm)
  • Have irregular astigmatism in the operative eye, or refractive cylinder resulting only from lenticular astigmatism in the operative eye
  • Have corneal pathology potentially affecting corneal topography, or other corneal abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period
  • Have undergone previous refractive corneal surgery in the operative eye
  • Have been diagnosed with any degenerative retinal disorders (e.g. soft drusen, macular degeneration or other progressive retinal disorders) in the operative eye that are predicted to cause future visual acuity losses to a level of 20/30 or worse during the postoperative follow-up time requirements of this study
  • Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Contact Hoya Surgical Optics, Inc. for Trial Locations

Chino Hills, California, 91709, United States

Location

Shepard Eye Center

Santa Maria, California, 93454, United States

Location

Mid-Florida Eye Center

Mt. Dora, Florida, 32757, United States

Location

Grosinger, Spigelman & Grey,

Bloomfield Hills, Michigan, 48302, United States

Location

Silverstein Eye Conters

Dansas City, Missouri, 64133, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

MeSH Terms

Conditions

AphakiaCataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Kees den Besten

    Hoya Surgical Optics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2010

First Posted

December 31, 2010

Study Start

December 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 6, 2015

Record last verified: 2015-02

Locations

US(6)