An Open-Label Evaluation of Degree of Accommodation in Pseudophakic Patients Bilaterally Implanted With Monofocal Intraocular Lenses

This study will determine the ability of three different intraocular lenses to accommodate in patients who have previously undergone bilateral intraocular lens implantation.

Completed

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Key information

Conditions

Pseudophakia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Center for Excellence in Eye Care

Miami, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients age 18 and older
Patients must have undergone cataract surgery and have bilateral implants of the same model. The models eligible for inclusion include:

Crystalens
Crysalens HD
Tecnis One monofocal
Patients must have a healthy cornea and macula
Patients must have 20/25 or better best corrected vision
Able to provide written informed consent

Exclusion criteria

BCVA of less than 20/25
On oral medications that could potentially block accommodation:

First generation antihistamines
Anticholinergic agents
Anti-psychotic medications
Antidepressant medications

Treatment and study plan

Primary outcomes

Amplitude of accommodation on COAS and how it correlates with: spherical aberration on the COAS, pupil size at near as measured with COAS, spherical aberration on the topography, patient reported nead for spectacles for reading

Time frame: one study visit

Secondary outcomes

Amplitude of accommodation on pushdown test - and how it compares to the COAS test results

Time frame: one study visit

Sponsors and collaborators

Lead sponsor

Innovative Medical

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Oct 30, 2009
Registry last updated: Jun 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed