Clinical trial NCT00428363: Effect of Optic Edge Design in a Silicone Intraocular Lens on Posterior Capsule Opacification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Pseudophakia
Keywords: posterior capsule opacification
PCO
after cataract
intraocular lens
optic edge design
sharp optic edge
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-01-30
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* bilateral, age related cataract

Exclusion Criteria:

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

Primary outcomes:
measure: amount of posterior capsule opacification (objective and subjective score 0-10)
Secondary outcomes:
measure: visual acuity
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dept. of Ophthalmology, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Rupert Menapace, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Oliver Findl, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.