NCT01191502

Completed

Comparative Study of Photopic and Mesopic Distance, Intermed...

Innovative Medical Source

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Other study identifiers

Sponsor study identifier

TMF-09-002

Study Type

observational

Estimated enrollment

50

Locations

1 country

Sites

1

Timeline

Study Start

January 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2011

Actual (reported)

Study Completion

September 2011

Actual (reported)

Brief Summary

The purpose of this study is to evaluate visual acuity in different lighting conditions (daylight and night time) and distances (distance, near and intermediate), and the independence of glasses, in patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 50 participants
Study completion date: September 2011
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2010
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
August 27, 2010
Actual (reported)
First Posted
August 30, 2010
Actual (reported)
Primary Completion
September 2011
Actual (reported)
Study Completion
September 2011
Actual (reported)

Last Updated: October 6, 2011
Status Verified: October 2011
Last Update Submitted: October 5, 2011

Conditions

Visual Acuity

Keywords

Patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.

Outcome Measures

Primary Outcomes (6)

Manifest refraction (monocular)
1 year
Uncorrected visual acuity (UCVA) ETDRS testing at distance, intermediate and near in photopic lighting (monocular and binocular)
1 year
Best distance-corrected visual acuity (BDCVA) ETDRS testing at distance, intermediate and near in photopic lighting (monocular and binocular)
1 year
Uncorrected visual acuity (UCVA) ETDRS testing at distance, intermediate and near in mesopic lighting (monocular and binocular)
1 year
Best distance-corrected visual acuity (BDCVA) ETDRS testing at distance, intermediate and near in mesopic lighting (monocular and binocular)
1 year
Photopic and mesopic pupillometry
1 year

Study Arms (2)

TECNIS MULTIFOCAL (TMF) INTRAOCULAR LENS

CRYSTALENS HD (CHD) INTRAOCULAR LENS

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Evaluate visual acuity in different lighting conditions (daylight and night time) and distances (distance, near and intermediate), and the independence of glasses, in patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.

You may qualify if:

years of age or older

Sponsors & Collaborators

Innovative Medical
Industrylead

Study Sites (1)

Oregon Health & Sciences University

Eugene, Oregon, 97401, United States

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: RETROSPECTIVE
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

August 27, 2010

First Posted

August 30, 2010

Study Start

January 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2011

Actual (reported)

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Status post bilateral cataract or refractive lens surgery (with or without LRI) and implantation of Tecnis™ Multifocal IOL or Crystalens™ HD Accommodating IOL

Best-corrected ETDRS equivalent visual acuity of 20/30 or better in each eye

Naturally dilated pupil size (in dim light) \> 3.5 mm (with no dilation medications) for both eyes

Clear intraocular media (no posterior capsular opacification, or status post YAG capsulotomy)

Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

You may not qualify if:

Ocular disease which could potentially limit uncorrected visual acuity or visual performance.
Use of systemic or ocular medications that may affect visual outcomes
Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
Uncontrolled systemic or ocular disease
History of ocular trauma
Amblyopia or strabismus
Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of worse than 20/30
Subjects who may be expected to require retinal laser treatment or other surgical intervention
Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
Pupil abnormalities (non-reactive, tonic pupils or abnormally shaped pupils)

Contact the study team to confirm eligibility.

Study Completion

September 2011

Actual (reported)

Last Updated

October 6, 2011

Record last verified: 2011-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01191502
Data provider: ClinicalTrials.gov
Source updated: 2011-10-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:39:15 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Study Arms (2)

TECNIS MULTIFOCAL (TMF) INTRAOCULAR LENS

CRYSTALENS HD (CHD) INTRAOCULAR LENS

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations