Application study with the light-adjustable intraocular lens LA

• Conditions: Astigmatism; H25.0; H25.1; H25.2; H25.8; H25.9; Q12.0; H26.0; H26.1; H52.2

• Registration Number: DRKS00010932
• Lead Sponsor: niversitätsklinikum Knappschaftskrankenhaus Bochum GmbH Augenklinik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2010-06-30
• Results First Posted: 2011-08-27
• Study Start: 2017-01-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• patients with age-related cataract, in which the natural lens has been removed by using of phacoemulsification by circular capsulorhexis of the anterior lens capsule. The posterior capsule is intraoperatively opened by a capsulorhexis to insert the lens optics in this opening
• Primary implantation of intraocular lens
• patients with an anticipated visual acuity of 0.5 or better on the clinical investigation
• patients with normal anterior segment

Exclusion Criteria

• already pre-existing pathological or physiological conditions, which can be degraded by the implantation of the intraocular lens, or may in the future can cause a decrease in visual acuity to 0.66, or worse. This also includes the findings indicated below and diagnoses:
• - microphthalmos
• - corneal dystrophies and endothelial pathologies
• - pseudoexfoliation lentis
• - High myopia
• - pars Planitis
• patients with corneal astigmatism, which is greater than one Diopter preoperative
• patients undergoing laser treatment of the retina is required
• Previous surgery on the cornea or intraocular surgery
• Condition after uveitis,
• Glaucoma, Diabetes mellitus with or without retinal involvement, age-related macular degeneration with the possibility of postoperative corrected visual acuity of 0.5 or better to deteriorate
• to fix Intraoperative complications such as rupture of the posterior capsule, zonulolysis, incomplete capsulorhexis, serious injury to the cornea or iris with the lack of opportunity, the lens at the intended location
• taking medications which have ocular side effects
• Patients who are already involved in other observational studies or trials
• one-eyed or functionally one-eyed patients
• Patients who do not appear to controls during the follow-up of 6 months or uncooperative are
• Children under 18 years

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ncorrected distance visual acuity by standard method (vision chart) on day 1, week 2 postoperatively (Lens is still variable by UV light); and at week 2, month 6, month 12 after LockIn (Lens can not be changed even by UV light)

Secondary Outcome Measures

Name	Time	Method
at<br>Week 2 postoperative week 2, month 1, month 3, month 6, month 12 post LockIn:<br><br>- Best corrected visual acuity by standard method (Visus-charts)<br>- Refraction by standard method<br>- Corneal keratometry using Scheinpflug-Camera<br>- Intraocular pressure using I-Care tonometer