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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01004549
Enrollment
30
Registered
2009-10-30
Start date
2009-10-31
Completion date
2011-06-30
Last updated
2011-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudophakia

Keywords

Patients who have previously undergone bilateral intraocular lens implantation

Brief summary

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

Interventions

None listed

Sponsors

Innovative Medical
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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 readingone study visit

Secondary

MeasureTime frame
Amplitude of accommodation on pushdown test - and how it compares to the COAS test resultsone study visit

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026