ClinicalTrials.gg
CompletedNCT01004549Updated Jun 28, 2011

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

An observational study in Pseudophakia, sponsored by Innovative Medical. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-28.

Sponsored by Innovative Medical · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Pseudophakia

Browse trials for

Keywords

  • Patients who have previously undergone bilateral intraocular lens implantation
03

In context

Pseudophakia

54 studies on the registry are indexed under Pseudophakia; 8 are open to participants now.

This study's planned enrollment of 30 is below the median of 71 across 26 observational studies indexed under Pseudophakia.

Browse Pseudophakia studies →

Lead sponsor

Innovative Medical is the lead sponsor of 51 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Primary care clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
30 participants (estimated)

Groups and cohorts

  • Bilateral intraocular lens implantation.
06

What researchers measure

Primary outcomes

  1. 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

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

    Time frame: one study visit

07

Study locations

1 site
  • The Center for Excellence in Eye Care
    Miami, Florida, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01004549
Lead sponsor
Innovative Medical
First posted
Oct 30, 2009
Start date
Oct 2009
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Jun 28, 2011

Study contacts

William Trattler, MD
principal investigator · The Center for Excellence in Eye Care
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion