Rayner Toric IOL Rotational Stability

Cataract Clinical Trial

— Rayner-toric  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02393313
• Other study ID #: 0670-14-TLV
• Status: Not yet recruiting
• Phase: N/A
• First received: December 8, 2014
• Last updated: March 18, 2015
• Start date: April 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2015
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Lior Lipsky, MD
• Phone: +972527360416
• Email: lior.lipsky[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Corneal Astigmatism

Intervention

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

Locations

Country	Name	City	State
Israel	Departent of Ophthalmlogy, Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Rayner Intraocular Lenses Limited

Country where clinical trial is conducted

Israel, 

References & Publications (5)

Alberdi T, Macías-Murelaga B, Bascarán L, Goñi 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. — View Citation

Becker KA, Auffarth GU, Völcker HE. [Measurement method for the determination of rotation and decentration of intraocular lenses]. Ophthalmologe. 2004 Jun;101(6):600-3. German. — View Citation

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. — View Citation

Hoffer KJ. Biometry of 7,500 cataractous eyes. Am J Ophthalmol. 1980 Sep;90(3):360-8. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOL off-axis rotation	IOL axis will be measured by slit lamp biomicroscopy and compared to the planned axis	3 months after surgery	No
Secondary	Uncorrected distance visual acuity		3 months after surgery	No
Secondary	Corrected distance visual acuity		3 months after surgery	No
Secondary	Subjective refraction		3 months after surgery	No