NCT01544777

Brief Summary

To evaluate visual acuity and quality of vision in participants undergoing cataract surgery with a Hoya model 751 intra-ocular lens and to compare the visual results to the common monofocal lens in use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 25, 2015

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

February 21, 2012

Last Update Submit

March 23, 2015

Conditions

AphakiaCataract

Keywords

AphakiaCataract

Outcome Measures

Primary Outcomes (1)

  • Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near

    Up to 3 months

Study Arms (3)

Both Eyes

EXPERIMENTAL

Model 751 IOL implanted in both eyes.

Device: Study IOL

Single eye

EXPERIMENTAL

Model 751 IOL in one eye

Device: Hoya iSert 751

Control

ACTIVE COMPARATOR

Aphakia treatment by negatively aspheric IOL implant, Hoya iSert model 251 or equivalent

Device: Negatively aspheric IOL

Interventions

Study IOLDEVICE

Aspheric IOL for correction of aphakia

Also known as: Hoya iSert 751 IOL
Both Eyes
Hoya iSert 751DEVICE

Model 751 in one eye, standard IOL in other eye

Also known as: Hoya iSert Model 751
Single eye
Negatively aspheric IOLDEVICE

Negatively aspheric IOL in both eyes

Also known as: Hoya iSert model 251 or equivalent
Control

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Senile cataract
  • Patient identified as a candidate for cataract surgery and IOL implantation
  • Willing to sign informed consent document approved by the Ethical Committee
  • Willing to complete all required tests and exams per this protocol

You may not qualify if:

  • Amblyopia
  • History or evidence of any ocular disease that may affect visual acuity
  • Previous ocular surgery, including refraction surgery
  • Ocular anomalies (e.g. microphthalmos, kerataconous)
  • Subjects with greater than 1.0 D of corneal astigmatism
  • Subjects who experience intraoperative complications that could affect postoperative IOL centration or tilt

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

AphakiaCataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Graham Barrett, MD

    Sir Charles Gairdner Hospital, Nedlans WA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2012

First Posted

March 6, 2012

Study Start

February 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 25, 2015

Record last verified: 2012-08

Locations

AU(1)