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A Prospective Observational Case Series of a Four-ring-haptic Acrylic One-piece IOL

NCT ID: NCT01244373

Last Updated: 2010-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-08-31

Brief Summary

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To describe biocompatibility, postoperative results and complications after implantation of the Corneal Quatrix Evolutive (Corneal, Croma, Austria) intraocular lens, a hydrophilic acrylic intraocular lens (IOL) with 4-haptic design and 360° sharp optic edge.

Detailed Description

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In this prospective case series the Corneal Quatrix Evolutive IOL was implanted in 14 eyes of nine patients with senile cortico-nuclear cataract. A standardized surgical technique and post-operative regimen were applied. Six months postoperatively best corrected visual acuity (BCVA), refraction and complications (especially) posterior capsule opacification (PCO) were analysed.

Conditions

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Cataract

Keywords

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Best-corrected visual acuity posterior capsule opacification QUATRIX® Aspheric Evolutive pre-loaded

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with senile cataract

Patients with senile cataract

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Patients with senile cortico-nuclear cataracts without previous intraocular surgery

Exclusion Criteria

* Dilated pupil size of \< 6 mm
* long-term anti-inflammatory treatment
* previous history of intraocular surgery
* previous history of corneal endothelial damage
* previous history of ocular trauma
* traumatic cataract
* history of uveitis
* diabetic retinopathy
* advanced macular degeneration
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of ophthalmology, General Hospital Linz

UNKNOWN

Sponsor Role collaborator

General Hospital Linz

OTHER

Sponsor Role lead

Locations

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Department of ophthalmology, General Hospital Linz

Linz, Upper Austria, Austria

Site Status

Countries

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Austria

References

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Kramer S, Schroder AC, Bruckner K, Jonescu-Cuypers C, Seitz B. [Subluxation of hydrophilic acrylate intraocular lenses due to massive capsular fibrosis]. Ophthalmologe. 2010 May;107(5):460-4. doi: 10.1007/s00347-009-2025-y. German.

Reference Type BACKGROUND
PMID: 19756637 (View on PubMed)

Michael K, O'Colmain U, Vallance JH, Cormack TG. Capsule contraction syndrome with haptic deformation and flexion. J Cataract Refract Surg. 2010 Apr;36(4):686-9. doi: 10.1016/j.jcrs.2009.09.042.

Reference Type BACKGROUND
PMID: 20362866 (View on PubMed)

Other Identifiers

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Quatrix01

Identifier Type: -

Identifier Source: org_study_id