Post-Approval Study of the TECNIS® Toric Extended Cylinder Range Intraocular Lens (IOL)
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| ClinicalTrials.gov Identifier: NCT02649842 |
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Recruitment Status :
Completed
First Posted : January 8, 2016
Results First Posted : December 27, 2019
Last Update Posted : January 22, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cataract Astigmatism | Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600 | Not Applicable |
The purpose of this study is to evaluate the performance of the higher cylinder (ZCT450,ZCT525 and ZCT600) toric IOLs. Some subjects had the higher cylinder toric IOLs in both eyes with other subjects having a higher cylinder toric IOL in one eye and the lower cylinder toric IOL in the other eye.
Per the statistical plan, data for the ZCT450/525/600 toric IOLs were to be pooled together and reported as one group.
The primary endpoint is the rate of severe visual distortions reported by subject at 6 months via questionnaire. The analysis population for this endpoint will be bilaterally implanted subjects with a high cylinder IOL (ZCT450/525/600) in the primary eye and a high cylinder IOL (ZCT450/525/600) or a low cylinder IOL (ZCT300/400) in the fellow eye.
There were no formal secondary endpoints. Data from a few other endpoints (rate of IOL repositioning due to IOL misalignment and percent change in cylinder) have been reported. For these endpoints the analysis population contains all subjects implanted with a ZCT450/525/600 in at least one eye.
Adverse events were reported by subject for all subjects with a high cylinder IOL (ZCT450/525/600) in at least one eye.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 101 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Post-Approval Study of the TECNIS® Toric IOL Extended Cylinder Range (ECR), Models ZCT450, ZCT525 and ZCT600 |
| Actual Study Start Date : | March 21, 2016 |
| Actual Primary Completion Date : | August 27, 2018 |
| Actual Study Completion Date : | January 28, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Extended Cylinder IOL
Approved toric intraocular lenses, Model ZCT450, ZCT525 or ZCT600
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Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600
Approved toric intraocular lens |
- Rate of Severe Visual Distortions [ Time Frame: 6 months ]Rate of severe visual distortions based on data from a self administered subject questionnaire
- Rate of IOL Repositioning Due to IOL Misalignment [ Time Frame: 6 months ]Rate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL
- Percent Change in Cylinder [ Time Frame: 6 months ]Percent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))*100
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| Ages Eligible for Study: | 22 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Minimum 22 years of age
- Bilateral cataracts
- Preoperative keratometric cylinder of at least 2.00 D in both eyes with at least one eye having approximately 3.00 D to 4.75 D of corneal astigmatism.
- Ability to understand, read and write English in order to consent to study participation and complete a study questionnaire
- Signed informed consent and HIPAA authorization
Exclusion Criteria:
- Irregular corneal astigmatism
- Any corneal pathology/abnormality other than regular corneal astigmatism
- Previous corneal surgery or recent ocular trauma or intraocular surgery that is not resolved/stable or may affect visual outcomes
- Any pupil abnormalities
- Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration
- Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study
- Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical study
- Planned monovision correction
- Patient is pregnant, plans to become pregnant or is lactating
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): NCT02649842
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| Study Director: | Devi Priya Janakiraman, OD,FAAO | Abbott Medical Optics |
Documents provided by Abbott Medical Optics:
| Responsible Party: | Abbott Medical Optics |
| ClinicalTrials.gov Identifier: | NCT02649842 |
| Other Study ID Numbers: |
TIOL-204-EPAS |
| First Posted: | January 8, 2016 Key Record Dates |
| Results First Posted: | December 27, 2019 |
| Last Update Posted: | January 22, 2020 |
| Last Verified: | January 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Cataract Astigmatism Lens Diseases Eye Diseases Refractive Errors |