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CompletedNCT00428363Updated Jan 30, 2007

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

A Phase 4 interventional study of Cataract surgery with implantation of an intraocular lens in Cataract and Pseudophakia, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2007-01-30.

Primary conditionCapsule OpacificationRegistry: CataractReclassifiedWhy we changed it
Registry
Cataract — the first condition term the registry derived for this study.
ClinicalTrials.gg
Capsule Opacification
Why
  1. The study's title name Capsule Opacification, a narrower term within Cataract.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Medical University of Vienna · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cataract
  • Pseudophakia

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Keywords

  • posterior capsule opacification
  • PCO
  • after cataract
  • intraocular lens
  • optic edge design
  • sharp optic edge
03

In context

Capsule Opacification Reclassified

28 studies on the registry are indexed under Capsule Opacification; 2 are open to participants now.

This study's enrollment of 52 is below the median of 63 across 16 interventional studies indexed under Capsule Opacification.

Browse Capsule Opacification studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.

Browse Medical University of Vienna studies →

Compared within Capsule Opacification, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cataract. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • bilateral, age related cataract

Exclusion criteria

Exclusion Criteria:

  • history of other ocular disease or intraocular surgery
  • diabetes requiring medical control
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
52 participants

Interventions

  • DeviceCataract surgery with implantation of an intraocular lens
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. visual acuity

07

Study locations

1 site
  • Dept. of Ophthalmology, Medical University of Vienna
    Vienna, 1090, Austria
08

References and documents

Publications

  • 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. PubMed 12106717 ↗
  • 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. PubMed 15975461 ↗
  • 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. PubMed 15313288 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2001 and a completion of Mar 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2007
First posted
Jan 30, 2007
Start
Jun 2001
Completion
Mar 2006
Last update
Jan 30, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Jan 30, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00428363
Lead sponsor
Medical University of Vienna
First posted
Jan 30, 2007
Start date
Jun 2001
Completion
Mar 2006
Last update
Jan 30, 2007

Study contacts

Rupert Menapace, MD
principal investigator · Medical University of Vienna
Oliver Findl, MD
principal investigator · Medical University of Vienna
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.

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Discussion

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