Pseudophakic Accommodation

Cataract Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716339
• Other study ID #: EK 481/2004
• Status: Completed
• Phase: N/A
• First received: July 9, 2008
• Last updated: July 14, 2008

Study information

• Verified date: July 2008
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Behavioral:
• motivation

Locations

Country	Name	City	State
Austria	Medical University Vienna, Department of Ophthalmology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity (best-corrected distance VA, distance-corrected near VA, best-corrected near VA)
Secondary	IOL shift (pilocarpine-, cyclopentolate- and nearpoint-induced) assessed with partial coherence interferometry