Pseudophakic Accommodation

NCT00716339 | Completed

• 1 other identifier: EK 481/2004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Keywords

pseudophakic accommodation

Outcome Measures

Primary Outcomes (1)

• visual acuity (best-corrected distance VA, distance-corrected near VA, best-corrected near VA)

Secondary Outcomes (1)

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

Study Arms (2)

1

ACTIVE COMPARATOR

motivated

Behavioral: motivation

2

NO INTERVENTION

control

Interventions

motivation BEHAVIORAL

1

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna, Department of Ophthalmology

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Cataract

Interventions

Information Motivation Behavioral Skills Model

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Models, Psychological; Models, Theoretical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 16, 2008
• Last Updated: July 16, 2008

Record last verified: 2008-07

Locations

AU (1)