Pseudophakic Accommodation
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
motivation
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring pseudophakic accommodation
Eligibility 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
Sites / Locations
- Medical University Vienna, Department of Ophthalmology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
motivated
control
Outcomes
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
Full Information
NCT ID
NCT00716339
First Posted
July 9, 2008
Last Updated
July 14, 2008
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00716339
Brief Title
Pseudophakic Accommodation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
pseudophakic accommodation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
motivated
Arm Title
2
Arm Type
No Intervention
Arm Description
control
Intervention Type
Behavioral
Intervention Name(s)
motivation
Primary Outcome Measure Information:
Title
visual acuity (best-corrected distance VA, distance-corrected near VA, best-corrected near VA)
Secondary Outcome Measure Information:
Title
IOL shift (pilocarpine-, cyclopentolate- and nearpoint-induced) assessed with partial coherence interferometry
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Medical University Vienna, Department of Ophthalmology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
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Pseudophakic Accommodation
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