Qu01: A Prospective Observational Case Series of a Four-ring-haptic Acrylic One-piece IOL

• Sponsor: General Hospital Linz (Other)
• Overall Status: Completed
• CT.gov ID: NCT01244373
• Collaborator: Department of ophthalmology, General Hospital Linz (Other)
• Enrollment: 9
• Location: 1
• Duration (Months): 15
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract

Detailed Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 9 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Observational Case Series of the Implantation of Intraocular Lens "QUATRIX® Aspheric Evolutive Pre-loaded".
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Patients with senile cataract Patients with senile cataract

Outcome Measures

Primary Outcome Measures

1. Best-corrected visual acuity (BCVA) [Six months]

   The best-corrected visual acuity is assessed with glasses after cataract operation

Secondary Outcome Measures

1. Posterior capsule opacification [Six months]

   The posterior capsule opacification is assessed by slit lamp examination and subjective grading

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of ophthalmology, General Hospital Linz	Linz	Upper Austria	Austria	4021

Sponsors and Collaborators

• General Hospital Linz
• Department of ophthalmology, General Hospital Linz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Kramer S, Schröder AC, Brückner 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.
• 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.

• ClinicalTrials.gov Identifier: NCT01244373
• Other Study ID Numbers: Quatrix01
• First Posted: Nov 19, 2010
• Last Update Posted: Nov 19, 2010
• Last Verified: Nov 1, 2010

• Keywords provided by , ,: Best-corrected visual acuity; posterior capsule opacification; QUATRIX® Aspheric Evolutive pre-loaded
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Nov 19, 2010