CataractRayner-toricNCT02393313
Rayner Toric IOL Rotational Stability
A study testing Cataract surgery and Rayner T-flex Toric IOLs in people with Cataract and Corneal Astigmatism, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Corneal Astigmatism
- What is being tested?
- Cataract surgery and Rayner T-flex Toric IOLs
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Corneal astigmatism ≥ 2.00 measured by IOLMaster
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Departent of Ophthalmlogy, Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
About this study
Official title: 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.
Read the 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.
- Conditions
- Cataract, Corneal Astigmatism
- Being tested
- Cataract surgery, Rayner T-flex Toric IOLs
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryProcedure or surgery
Rayner T-flex Toric IOLs (573T / 623T; Rayner Intraocular Lenses Ltd,East Sussex, United Kingdom) will be implanted in the lens capsule
Rayner T-flex Toric IOLsDevice
| Study group | Role | What they receive |
|---|---|---|
| Cataract surgery toric intraocular lens | Experimental | Rayner T-flex Toric IOLs (573T / 623T; Rayner Intraocular Lenses Ltd,East Sussex, United Kingdom) will be implanted in the lens capsule Receives: Procedure: Cataract surgery; Device: Rayner T-flex Toric IOLs |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL off-axis rotation
IOL axis will be measured by slit lamp biomicroscopy and compared to the planned axis
Measured: 3 months after surgery
Secondary outcomes (3)
Uncorrected distance visual acuity
Measured: 3 months after surgery
Corrected distance visual acuity
Measured: 3 months after surgery
Subjective refraction
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Rayner Intraocular Lenses Limited
- Responsible party
- Sponsor
- Investigators
- Adi Michaeli, MD, Principal investigator, michaeli.adi@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393313
- Sponsor's protocol ID
- 0670-14-TLV
- Acronym
- Rayner-toric
- Status last verified
- Mar 2015
- First submitted
- 8 Dec 2014
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 7425052Tehrani 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.
PubMed 12881648Becker 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.
PubMed 15197576Entabi 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.
PubMed 21241904Alberdi 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.
PubMed 23061999
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Rayner T-flex Toric Intra-Ocular Lens for Spherical and Astigmatic Correction, and Rotational Stability
- ClinicalTrials.gov ID
- NCT02393313
- Acronym / sponsor ID
- Rayner-toric / 0670-14-TLV
- Conditions
- Cataract, Corneal Astigmatism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Rayner Intraocular Lenses Limited
- Study start
- Apr 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cataract surgery toric intraocular lens | Experimental | Procedure: Cataract surgery, Device: Rayner T-flex Toric IOLsRayner T-flex Toric IOLs (573T / 623T; Rayner Intraocular Lenses Ltd,East Sussex, United Kingdom) will be implanted in the lens capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Corneal astigmatism ≥ 2.00 measured by IOLMaster
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract surgeryRayner T-flex Toric IOLs (573T / 623T; Rayner Intraocular Lenses Ltd,East Sussex, United Kingdom) will be implanted in the lens capsule | Procedure or surgery | Cataract surgery toric intraocular lens |
| Rayner T-flex Toric IOLs | Device | Cataract surgery toric intraocular lens |
Primary outcome
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
3 secondary outcomes
Uncorrected distance visual acuity
Time frame: 3 months after surgery
Corrected distance visual acuity
Time frame: 3 months after surgery
Subjective refraction
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- Background: PubMed 7425052Hoffer 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.
- Background: PubMed 12881648Tehrani 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.
- Background: PubMed 15197576Becker 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.
- Background: PubMed 21241904Entabi 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.
- Background: PubMed 23061999Alberdi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adi Michaeli, MD principal investigator
michaeli.adi@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery and Rayner T-flex Toric IOLs in people with Cataract and Corneal Astigmatism, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lior Lipsky, MD (+972527360416, lior.lipsky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOL off-axis rotation (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02393313, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.