Pseudophakic Accommodation

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Behavioral: motivation

• Study Type: Interventional
• Enrollment: 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University Vienna, Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; motivated	Behavioral: motivation
No Intervention: 2; control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
visual acuity (best-corrected distance VA, distance-corrected near VA, best-corrected near VA)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: July 9, 2008
• First Submitted That Met QC Criteria: July 14, 2008
• First Posted (Estimate): July 16, 2008

Study Record Updates

• Last Update Posted (Estimate): July 16, 2008
• Last Update Submitted That Met QC Criteria: July 14, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: pseudophakic accommodation
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: EK 481/2004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No