NCT01505816

Brief Summary

This prospective nonrandomized study comprised patients with cataract, corneal astigmatism, and motivation for spectacle independence. In all cases, a Rayner M-flex® T toric Intraocular Lens will be implanted in the capsular bag. Three months postoperatively, distance, intermediate, and near visual acuities; spherical equivalent; residual refractive astigmatism; defocus curve; and contrast sensitivity will be evaluated. A patient-satisfaction and visual phenomena questionnaire will also be administered.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

October 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2012

Completed
Last Updated

January 9, 2012

Status Verified

January 1, 2012

Enrollment Period

1 month

First QC Date

January 3, 2012

Last Update Submit

January 6, 2012

Conditions

Cataract

Keywords

CataractVisionIntraocular lensMultifocalToric

Outcome Measures

Primary Outcomes (1)

  • Visual Performance After Implantation of a Toric Multifocal Refractive Intraocular Lens

    Postoperative evaluation will be performed at 3 months. The uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) will be assessed using the 100% contrast ETDRS chart; a binocular defocus curve will be constructed using the ETDRS chart at 4 m.

    3 months postoperative

Secondary Outcomes (2)

  • Contrast sensitivity

    3 months

  • Patient satisfaction

    3 months

Study Arms (1)

Toric

NO INTERVENTION

Multifocal Toric IOL implantation

Device: Multifocal Intraocular Lens (RAYNER M-FLEX T TORIC IOL)

Interventions

Multifocal Intraocular Lens (RAYNER M-FLEX T TORIC IOL)DEVICE

Multifocal IOL implantation

Also known as: RAYNER M-FLEX T TORIC IOL
Toric

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cataract
  • Any race
  • Either gender
  • Diagnosis of cataracts both eyes
  • Pre-existing physical conditions that could skew visual results, such as Diabetes, Retinal detachment, Macular degeneration, or Cancer
  • Subjects must have \> 1.00 diopter of astigmatism

You may not qualify if:

  • Central endothelial cell count less than 2000 cells/mm2 glaucoma or intraocular pressure greater than 21 mmHg amblyopia
  • Retinal abnormalities
  • Diabetes mellitus steroid or immunosuppressive treatment
  • Connective tissue diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Oftalmologico Brasilia

Brasília, Federal District, 70200670, Brazil

Location

Related Publications (3)

  • Alio JL, Pinero DP, Tomas J, Plaza AB. Vector analysis of astigmatic changes after cataract surgery with implantation of a new toric multifocal intraocular lens. J Cataract Refract Surg. 2011 Jul;37(7):1217-29. doi: 10.1016/j.jcrs.2010.12.064.

    PMID: 21700102BACKGROUND

  • Mojzis P, Pinero DP, Studeny P, Tomas J, Korda V, Plaza AB, Alio JL. Comparative analysis of clinical outcomes obtained with a new diffractive multifocal toric intraocular lens implanted through two types of corneal incision. J Refract Surg. 2011 Sep;27(9):648-57. doi: 10.3928/1081597X-20110506-01. Epub 2011 May 20.

    PMID: 21598872BACKGROUND

  • Visser N, Nuijts RM, de Vries NE, Bauer NJ. Visual outcomes and patient satisfaction after cataract surgery with toric multifocal intraocular lens implantation. J Cataract Refract Surg. 2011 Nov;37(11):2034-42. doi: 10.1016/j.jcrs.2011.05.041. Epub 2011 Sep 22.

    PMID: 21940140RESULT

MeSH Terms

Conditions

Cataract

Interventions

Multifocal Intraocular Lenses

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Lenses, IntraocularLensesOptical DevicesEquipment and SuppliesProstheses and Implants

Study Officials

  • PATRICK F TZELIKIS, MD, PhD

    HOSPITAL OFTALMOLOGICO BRASILIA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2012

First Posted

January 9, 2012

Study Start

October 1, 2011

Primary Completion

November 1, 2011

Study Completion

January 1, 2012

Last Updated

January 9, 2012

Record last verified: 2012-01

Locations

BR(1)