Rayner-toric: Rayner Toric IOL Rotational Stability

Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02393313
Collaborator
Rayner Intraocular Lenses Limited (Industry)
50
Enrollment
1
Location
1
Arm
44
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Cataract surgery
  • Device: Rayner T-flex Toric IOLs
N/A

Detailed Description

Background During cataract surgery, an intraocular lens is implanted in the bag. A monofocal lens allows spherical correction only. 15% to 29% of patients with cataracts have more than 1.50 diopters of astigmatism according to current estimations.1 Astigmatic correction can be performed during cataract surgery: the main clear corneal incision can be done at the steep axis, limbal relaxing incisions (LRI) or by opposite clear corneal incision (OCCI) can be performed. These techniques are not fully predictable and stable over time.2 Optimal corneal astigmatic correction can be done by implantation of a toric intra-ocular lens(IOL), with predictable and stable results over time. The toric IOL must be positioned in the correct axis. Rotation of the lens will reduce the astigmatic correction. Approximately one degree of off-axis rotation results in a loss of up to 3.3% of the cylinder power. 3 It is crucial for the intraocular lens to keep its correct axis for optimal astigmatic correction.

A number of toric intraocular lens are approved for implantation such as - Acrysof toric (Alcon), Tecnis toric IOL (Abbott medical), STAAR toric IOL (STAAR surgical company). This study will examine T-flex (Rayner) IOL. The rotational and refractive stability of this IOL has been tested on a relatively small number of patients. 4, 5

Objective Examination of Rayner T-flex Toric IOLs (573T and 623T; Rayner Intraocular Lenses Ltd,East Sussex, United Kingdom) for spherical and astigmatic correction, and rotational stability.

Methods Prospective study on 50 eyes. Patients will be recruited during examination in pre-operative clinic. This examinations include visual acuity, slit-lamp biomicroscopy, applanation tonometry, fundus examination after instillation of tropicamide 0.5% and phenylephrine 10%, IOL calculation with IOLMaster(Zeiss), which also measures corneal astigmatism. After acquiring informed consent, further examinations will be done including corneal topography with Galilei Dual Scheimpflug Analyzer ( Zeimer Ophthalmology), and Tomey keratometer, auto-refractometry and subjective refraction.

Since corneal astigmatism is often binocular, patients with second eye corneal astigmatism, will be offered a toric IOL, even if unsuitable for inclusion in this study. All operations will be done by a senior surgeon, experienced in toric IOL implantations. Rayner T-flex Toric IOLs (573T / 623T; Rayner Intraocular Lenses Ltd,East Sussex, United Kingdom) will be implanted. IOL calculation will be done using Ranyer's online calculator (WWW.TORICIOL.RAYNER.COM).

Post-operative examination will include IOL axis measurements, IOL photography and refraction after a week, month and three months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Examination of Rayner T-flex Toric Intra-Ocular Lens for Spherical and Astigmatic Correction, and Rotational Stability
Study Start Date :
Apr 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

ArmIntervention/Treatment
Experimental: Cataract surgery toric intraocular lens

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

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

Device: Rayner T-flex Toric IOLs

Outcome Measures

Primary Outcome Measures

  1. IOL off-axis rotation [3 months after surgery]

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

Secondary Outcome Measures

  1. Uncorrected distance visual acuity [3 months after surgery]

  2. Corrected distance visual acuity [3 months after surgery]

  3. Subjective refraction [3 months after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Corneal astigmatism ≥ 2.00 measured by IOLMaster
Exclusion Criteria:
  • 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Departent of Ophthalmlogy, Tel Aviv Sourasky Medical CenterTel AvivIsrael64239

Sponsors and Collaborators

  • Tel-Aviv Sourasky Medical Center
  • Rayner Intraocular Lenses Limited

Investigators

  • Principal Investigator: Adi Michaeli, MD, michaeli.adi@gmail.com

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT02393313
Other Study ID Numbers:
  • 0670-14-TLV
First Posted:
Mar 19, 2015
Last Update Posted:
Mar 19, 2015
Last Verified:
Mar 1, 2015
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 19, 2015