Pseudophakic Accommodation

NCT ID: NCT00716339

Last Updated: 2008-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Cataract

Keywords

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pseudophakic accommodation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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1

motivated

Group Type ACTIVE_COMPARATOR

motivation

Intervention Type BEHAVIORAL

2

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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motivation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Locations

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Medical University Vienna, Department of Ophthalmology

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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EK 481/2004

Identifier Type: -

Identifier Source: org_study_id