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Rayner Toric IOL Rotational Stability (Rayner-toric)

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ClinicalTrials.gov Identifier: NCT02393313
Recruitment Status : Not yet recruiting
First Posted : March 19, 2015
Last Update Posted : March 19, 2015
Sponsor:
Collaborator:
Rayner Intraocular Lenses Limited
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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 disease Intervention/treatment Phase
Cataract Corneal Astigmatism Procedure: Cataract surgery Device: Rayner T-flex Toric IOLs Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
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 : April 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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



Primary Outcome Measures :
  1. IOL off-axis rotation [ Time Frame: 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 [ Time Frame: 3 months after surgery ]
  2. Corrected distance visual acuity [ Time Frame: 3 months after surgery ]
  3. Subjective refraction [ Time Frame: 3 months after surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393313


Contacts
Contact: Lior Lipsky, MD +972527360416 lior.lipsky@gmail.com

Locations
Israel
Departent of Ophthalmlogy, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Rayner Intraocular Lenses Limited
Investigators
Principal Investigator: Adi Michaeli, MD michaeli.adi@gmail.com