NCT02393313

Brief Summary

This study evaluates the Rayner T-flex Toric IOLs for spherical and astigmatic correction, and rotational stability in cataract surgery. 50 patients with cataract and corneal astigmatism \>= 2 diopters will undergo cataract surgery, with implantation of Rayner toric intraocular lens. Post-operative examination will include IOL axis measurements and refraction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 8, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

2.7 years

First QC Date

December 8, 2014

Last Update Submit

March 18, 2015

Conditions

CataractCorneal Astigmatism

Outcome Measures

Primary Outcomes (1)

  • IOL off-axis rotation

    IOL axis will be measured by slit lamp biomicroscopy and compared to the planned axis

    3 months after surgery

Secondary Outcomes (3)

  • Uncorrected distance visual acuity

    3 months after surgery

  • Corrected distance visual acuity

    3 months after surgery

  • Subjective refraction

    3 months after surgery

Study Arms (1)

Cataract surgery toric intraocular lens

EXPERIMENTAL

Rayner T-flex Toric IOLs (573T / 623T; Rayner Intraocular Lenses Ltd,East Sussex, United Kingdom) will be implanted in the lens capsule

Procedure: Cataract surgeryDevice: Rayner T-flex Toric IOLs

Interventions

Cataract surgeryPROCEDURE

Rayner T-flex Toric IOLs (573T / 623T; Rayner Intraocular Lenses Ltd,East Sussex, United Kingdom) will be implanted in the lens capsule

Cataract surgery toric intraocular lens
Rayner T-flex Toric IOLsDEVICE
Cataract surgery toric intraocular lens

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Corneal astigmatism ≥ 2.00 measured by IOLMaster

You may not qualify if:

  • Pterygium (can be included 6 months after successful surgical excision)
  • Corneal pathologies including corneal scars causing corneal irregularity
  • Severe dry eye
  • Traumatic cataract
  • Pregnant women
  • Severe macular disease or macular atrophy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departent of Ophthalmlogy, Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (5)

  • Hoffer KJ. Biometry of 7,500 cataractous eyes. Am J Ophthalmol. 1980 Sep;90(3):360-8. doi: 10.1016/s0002-9394(14)74917-7. No abstract available.

    PMID: 7425052BACKGROUND

  • Tehrani M, Dick HB. Incisional keratotomy to toric intraocular lenses: an overview of the correction of astigmatism in cataract and refractive surgery. Int Ophthalmol Clin. 2003 Summer;43(3):43-52. doi: 10.1097/00004397-200343030-00005. No abstract available.

    PMID: 12881648BACKGROUND

  • Becker KA, Auffarth GU, Volcker HE. [Measurement method for the determination of rotation and decentration of intraocular lenses]. Ophthalmologe. 2004 Jun;101(6):600-3. doi: 10.1007/s00347-003-0951-7. German.

    PMID: 15197576BACKGROUND

  • Entabi M, Harman F, Lee N, Bloom PA. Injectable 1-piece hydrophilic acrylic toric intraocular lens for cataract surgery: efficacy and stability. J Cataract Refract Surg. 2011 Feb;37(2):235-40. doi: 10.1016/j.jcrs.2010.08.040.

    PMID: 21241904BACKGROUND

  • Alberdi T, Macias-Murelaga B, Bascaran L, Goni N, de Arregui SS, Mendicute J. Rotational stability and visual quality in eyes with Rayner toric intraocular lens implantation. J Refract Surg. 2012 Oct;28(10):696-701. doi: 10.3928/1081597X-20120921-04.

    PMID: 23061999BACKGROUND

MeSH Terms

Conditions

CataractAstigmatism

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Adi Michaeli, MD

    michaeli.adi@gmail.com

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lior Lipsky, MD

CONTACT

+972527360416lior.lipsky@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2014

First Posted

March 19, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

IL(1)