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Rayner Toric IOL Rotational Stability (Rayner-toric)

Primary Purpose

Cataract, Corneal Astigmatism

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Cataract surgery
Rayner T-flex Toric IOLs
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Departent of Ophthalmlogy, Tel Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cataract surgery toric intraocular lens

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Uncorrected distance visual acuity
Corrected distance visual acuity
Subjective refraction

Full Information

First Posted
December 8, 2014
Last Updated
March 18, 2015
Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Rayner Intraocular Lenses Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02393313
Brief Title
Rayner Toric IOL Rotational Stability
Acronym
Rayner-toric
Official Title
Examination of Rayner T-flex Toric Intra-Ocular Lens for Spherical and Astigmatic Correction, and Rotational Stability
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Rayner Intraocular Lenses Limited

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Corneal Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cataract surgery toric intraocular lens
Arm Type
Experimental
Arm Description
Rayner T-flex Toric IOLs (573T / 623T; Rayner Intraocular Lenses Ltd,East Sussex, United Kingdom) will be implanted in the lens capsule
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
Rayner T-flex Toric IOLs (573T / 623T; Rayner Intraocular Lenses Ltd,East Sussex, United Kingdom) will be implanted in the lens capsule
Intervention Type
Device
Intervention Name(s)
Rayner T-flex Toric IOLs
Primary Outcome Measure Information:
Title
IOL off-axis rotation
Description
IOL axis will be measured by slit lamp biomicroscopy and compared to the planned axis
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Uncorrected distance visual acuity
Time Frame
3 months after surgery
Title
Corrected distance visual acuity
Time Frame
3 months after surgery
Title
Subjective refraction
Time Frame
3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lior Lipsky, MD
Phone
+972527360416
Email
lior.lipsky@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adi Michaeli, MD
Organizational Affiliation
michaeli.adi@gmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departent of Ophthalmlogy, Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
7425052
Citation
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.
Results Reference
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PubMed Identifier
12881648
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. doi: 10.1097/00004397-200343030-00005. No abstract available.
Results Reference
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PubMed Identifier
15197576
Citation
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.
Results Reference
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PubMed Identifier
21241904
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.
Results Reference
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PubMed Identifier
23061999
Citation
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.
Results Reference
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Rayner Toric IOL Rotational Stability

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