Rayner Toric IOL Rotational Stability (Rayner-toric)

Examination of Rayner T-flex Toric Intra-Ocular Lens for Spherical and Astigmatic Correction, and Rotational Stability

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.

Study Overview

• Status: Unknown
• Conditions: Cataract; Corneal Astigmatism
• Intervention / Treatment: Procedure: Cataract surgery; Device: Rayner T-flex Toric IOLs

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lior Lipsky, MD; Phone Number: +972527360416; Email: lior.lipsky@gmail.com

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Departent of Ophthalmlogy, Tel Aviv Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOL off-axis rotation	IOL axis will be measured by slit lamp biomicroscopy and compared to the planned axis	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Uncorrected distance visual acuity	3 months after surgery
Corrected distance visual acuity	3 months after surgery
Subjective refraction	3 months after surgery

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: Rayner Intraocular Lenses Limited
• Investigators: Principal Investigator: Adi Michaeli, MD, michaeli.adi@gmail.com

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Estimate): March 19, 2015
• Last Update Submitted That Met QC Criteria: March 18, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: 0670-14-TLV