Clinical Evaluation of Toric Intraocular Lens
Safety and Effectiveness Evaluation of Toric Intraocular Lens
1 other identifier
interventional
64
0 countries
N/A
Brief Summary
Evaluate efficacy and safety of the toric IOL implanted into aphakic eye with corneal astigmatism after cataract surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 16, 2017
CompletedFirst Posted
Study publicly available on registry
August 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 20, 2018
February 1, 2018
2.4 years
June 16, 2017
February 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Visual acuity
Visual acuity with pre-determined spherical correction
postoperative 6 months
Secondary Outcomes (2)
Visual acuity
postoperative 6 months
IOL rotation
postoperative 6 months
Other Outcomes (1)
Adverse events
one year
Study Arms (1)
toric intraocular lens
EXPERIMENTALtoric intraocular lens is implanted to all subjects
Interventions
Eligibility Criteria
You may qualify if:
- Patients with age of 40 years or older
- Patients with age-related cataract in one eye or both eyes.
- Patients willing to participate in the required postoperative study.
- Patient who can understand and sign the consent document.
- An eye whose pupil diameter after mydriasis is 5 mm or greater.
- An eye whose preoperative corneal cylindrical power is 1.0D or more.
- An eye whose postoperative astigmatism is predicted to be less than 0.5 D.
- An eye whose postoperative visual acuity with spherical addition is 0.8 D or more.
You may not qualify if:
- Disorder of corneal endothelium
- Uncontrolled glaucoma
- Active Uveitis
- Diabetic retinopathy
- Retinal detachment
- Congenital ocular anomalies
- Choroidal hemorrhage
- Shallow anterior chamber
- Microphthalmus
- Corneal dystrophy
- Optic atrophy
- Ocular hypertension
- Amblyopia
- Previous history of corneal transplantation
- Active Iritis
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nidek Co. LTD.lead
Related Publications (1)
Sugita I, Ogawa T, Ichikawa K, Okita T, Negishi K, Nakano T, Tsuneoka H. Rotational stability and clinical outcomes of a new one piece toric intraocular lens with anchor-wing haptics. BMC Ophthalmol. 2022 Jan 15;22(1):26. doi: 10.1186/s12886-021-02240-7.
PMID: 35033047DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2017
First Posted
August 8, 2017
Study Start
December 1, 2014
Primary Completion
May 1, 2017
Study Completion
December 1, 2017
Last Updated
February 20, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share