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Pseudophakic Accommodation

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00716339
First received: July 9, 2008
Last updated: July 14, 2008
Last verified: July 2008
History of Changes
  Purpose

Purpose:

The aim of this study was to compare the effect of ciliary body training as proposed by manufacturers of accommodating IOLs and patient motivation on the pseudoaccommodative ability with a standard intraocular lens (SA60AT).

Setting:

Department of Ophthalmology, Medical University of Vienna.

Methods:

This randomized, controlled, examiner-masked study comprised 80 eyes of 40 patients that underwent standard cataract surgery. Patients were randomly assigned to a "motivated" or "non-motivated" (control) group. In the motivated group, subjects were told to take part in a special protocol to improve their near-reading ability after cataract surgery and were instructed not to use near adds for at least 3 months. Follow-up examinations included best-corrected distance visual acuity (VA), distance-corrected near VA, best-corrected near VA, defocus curve and reading speed, as well as pilocarpine-, cyclopentolate- and nearpoint-induced IOL shift assessed with partial coherence interferometry.


Condition Intervention
Cataract
 Behavioral: motivation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • visual acuity (best-corrected distance VA, distance-corrected near VA, best-corrected near VA)

Secondary Outcome Measures:
  • IOL shift (pilocarpine-, cyclopentolate- and nearpoint-induced) assessed with partial coherence interferometry

Estimated Enrollment: 40
Arms Assigned Interventions
Active Comparator: 1
motivated
 Behavioral: motivation
No Intervention: 2
control

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients suffering from age-related cataract who are enrolled for cataract surgery.
  • Age 50 to 75 years
  • < 1 D of corneal astigmatism, estimated postoperative VA of 20/30 or better and IOL power between 16 and 27 dpt

Exclusion Criteria:

  • Patients with complications during cataract surgery or during the postoperative period, significant other ophthalmic diseases such as glaucoma, diabetic retinopathy, etc., or ophthalmic surgery other than cataract surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716339

Locations
Austria
Medical University Vienna, Department of Ophthalmology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00716339     History of Changes
Other Study ID Numbers: EK 481/2004
Study First Received: July 9, 2008
Last Updated: July 14, 2008
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
pseudophakic accommodation

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013