NCT01075542

Brief Summary

The purpose of this study is to determine if Toric intraocular lens implantation in cataract surgery is a more efficient and cost-effective treatment of astigmatism than Monofocal intraocular lens implantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

2.7 years

First QC Date

February 24, 2010

Last Update Submit

January 13, 2014

Conditions

Astigmatism

Keywords

Corneal astigmatismIntraocular lens

Outcome Measures

Primary Outcomes (1)

  • Spectacle independency

    Spectacle independency for distance vision

    preop, 3 months and 6 months postop

Secondary Outcomes (6)

  • Visual acuity

    preop, 1 day, 1 month, 3 months and 6 months postop

  • Refractive astigmatism

    preop, 3 months and 6 months postop

  • Higher-order wavefront aberrations

    preop, 3 months and 6 months postop

  • Contrast sensitivity

    preop, 3 months and 6 months postop

  • Costs related to intervention

    preop, 3 and 6 months postop

  • +1 more secondary outcomes

Study Arms (2)

Toric intraocular lens

EXPERIMENTAL

Bilateral Toric intraocular lens implantation in cataract surgery

Device: AcrySof Toric intraocular lens, model SN60TT

Monofocal intraocular lens

OTHER

Bilateral Monofocal intraocular lens implantation in cataract surgery

Device: AcrySof Monofocal IOL, model SN60AT

Interventions

AcrySof Toric intraocular lens, model SN60TTDEVICE

The lens is made of foldable acrylic material and is implanted in the capsular bag

Toric intraocular lens
AcrySof Monofocal IOL, model SN60ATDEVICE

The lens is made of foldable acrylic material and is implanted in the capsular bag

Monofocal intraocular lens

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral cataract
  • Bilateral corneal astigmatism (at least 1.25D)
  • Predicted residual astigmatism less than 0.5D

You may not qualify if:

  • Irregular corneal astigmatism or keratoconus
  • Fuchs endothelial dystrophy (stage 2)
  • Expected postoperative best-corrected visual acuity worse than logMAR +0.3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Atrium Medical Center

Heerlen, Brunssum, Kerkrade, Netherlands

Location

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

Location

Rotterdam Eye Hospital

Rotterdam, Netherlands

Location

Related Publications (2)

  • Bauer NJ, de Vries NE, Webers CA, Hendrikse F, Nuijts RM. Astigmatism management in cataract surgery with the AcrySof toric intraocular lens. J Cataract Refract Surg. 2008 Sep;34(9):1483-8. doi: 10.1016/j.jcrs.2008.05.031.

    PMID: 18721707BACKGROUND

  • Visser N, Beckers HJ, Bauer NJ, Gast ST, Zijlmans BL, Berenschot TT, Webers CA, Nuijts RM. Toric vs aspherical control intraocular lenses in patients with cataract and corneal astigmatism: a randomized clinical trial. JAMA Ophthalmol. 2014 Dec;132(12):1462-8. doi: 10.1001/jamaophthalmol.2014.3602.

    PMID: 25256624DERIVED

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Rudy Nuijts, MD, PhD

    Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2010

First Posted

February 25, 2010

Study Start

February 1, 2010

Primary Completion

October 1, 2012

Study Completion

November 1, 2012

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

NL(3)