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Effect of Optic Edge Design in a Silicone Intraocular Lens on Posterior Capsule Opacification

Primary Purpose

Cataract, Pseudophakia

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Cataract surgery with implantation of an intraocular lens
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cataract focused on measuring posterior capsule opacification, PCO, after cataract, intraocular lens, optic edge design, sharp optic edge

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • bilateral, age related cataract

Exclusion Criteria:

  • history of other ocular disease or intraocular surgery
  • diabetes requiring medical control

Sites / Locations

  • Dept. of Ophthalmology, Medical University of Vienna

Outcomes

Primary Outcome Measures

amount of posterior capsule opacification (objective and subjective score 0-10)

Secondary Outcome Measures

visual acuity

Full Information

First Posted
January 29, 2007
Last Updated
January 29, 2007
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00428363
Brief Title
Effect of Optic Edge Design in a Silicone Intraocular Lens on Posterior Capsule Opacification
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

5. Study Description

Brief Summary
Purpose: To compare the posterior capsule opacification (PCO) inhibiting effect of the sharp posterior optic edge design of the Clariflex silicone intraocular lens (IOL) with that of the double-round edge design of the SI40 (Phacoflex) silicone IOL over a period of 3 years. Setting: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. Methods: Fifty-two patients with bilateral age-related cataract (104 eyes) were included in this randomized, prospective, bilateral, patient- and examiner-masked clinical trial with intra-individual comparison. Each study patient had cataract surgery in both eyes and received an SI40 IOL (anterior and posterior round optic edges) in one eye and a Clariflex IOL with OptiEdge (round anterior and sharp posterior optic edge) in the other eye. Follow-up examinations were at one week, one month, six months, one, two, and three years. Digital retroillumination images were taken of each eye. The amount of PCO was assessed subjectively at the slit-lamp and objectively using automated image analysis software (AQUA) one, two, and three years after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Pseudophakia
Keywords
posterior capsule opacification, PCO, after cataract, intraocular lens, optic edge design, sharp optic edge

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
52 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Cataract surgery with implantation of an intraocular lens
Primary Outcome Measure Information:
Title
amount of posterior capsule opacification (objective and subjective score 0-10)
Secondary Outcome Measure Information:
Title
visual acuity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: bilateral, age related cataract Exclusion Criteria: history of other ocular disease or intraocular surgery diabetes requiring medical control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rupert Menapace, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Ophthalmology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
12106717
Citation
Buehl W, Findl O, Menapace R, Rainer G, Sacu S, Kiss B, Petternel V, Georgopoulos M. Effect of an acrylic intraocular lens with a sharp posterior optic edge on posterior capsule opacification. J Cataract Refract Surg. 2002 Jul;28(7):1105-11. doi: 10.1016/s0886-3350(02)01371-8.
Results Reference
background
PubMed Identifier
15975461
Citation
Buehl W, Findl O, Menapace R, Sacu S, Kriechbaum K, Koeppl C, Wirtitsch M. Long-term effect of optic edge design in an acrylic intraocular lens on posterior capsule opacification. J Cataract Refract Surg. 2005 May;31(5):954-61. doi: 10.1016/j.jcrs.2004.09.053.
Results Reference
background
PubMed Identifier
15313288
Citation
Buehl W, Menapace R, Sacu S, Kriechbaum K, Koeppl C, Wirtitsch M, Georgopoulos M, Findl O. Effect of a silicone intraocular lens with a sharp posterior optic edge on posterior capsule opacification. J Cataract Refract Surg. 2004 Aug;30(8):1661-7. doi: 10.1016/j.jcrs.2004.02.051.
Results Reference
result
Links:
URL
http://www.meduniwien.ac.at/iol/
Description
Homepage of the Vienna IOL Study Group (Dept. of Ophthalmology, Medical University of Vienna)

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Effect of Optic Edge Design in a Silicone Intraocular Lens on Posterior Capsule Opacification

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