Pseudophakic Accommodation - Full Text View

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00716339

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

MedlinePlus related topics: Cataract

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control, Parallel Assignment

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
1: Active Comparator motivated	Behavioral: motivation
2: No Intervention 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

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

Keywords provided by Medical University of Vienna:

pseudophakic accommodation

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on January 16, 2009