Clinical Evaluation of Toric Intraocular Lens

Cataract Clinical Trial

Official title:

Safety and Effectiveness Evaluation of Toric Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242486
• Other study ID #: TIOL-YST
• Status: Completed
• Phase: N/A
• First received: June 16, 2017
• Last updated: February 18, 2018
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Nidek Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate efficacy and safety of the toric IOL implanted into aphakic eye with corneal astigmatism after cataract surgery.

Description:

Effectiveness

• primary endpoint is visual acuity with pre-determined spherical correction.

• secondary endpoint is UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent, IOL rotation

Safety

• number and percentage of adverse event

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• Corneal disorder

• Macular degeneration

• Retinal degeneration

• Clinically significant change in macula and/or retinal pigment epithelium

• Corneal irregular astigmatism

• Atopic disease

• Brittleness of Zinn's zonule, fractured zonule and lens luxation (including subluxation)

• Pseudo-exfoliation syndrome

• Iris neovascularization

• Long axis length eye (axis length : 28mm or more)

• Severe dry eye, abnormality of the lens surface

• Concurrent participation in another drug and device clinical investigation

• Patient with mental deficiency or psychiatric disorder and/or who is not capable of expressing the consent of participating in the trial

• Patient who is judged inappropriate by investigators or sub-investigators

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

Device:
• toric intraocular lens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nidek Co. LTD.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Severity and causal relationship	one year
Primary	Visual acuity	Visual acuity with pre-determined spherical correction	postoperative 6 months
Secondary	Visual acuity	UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent	postoperative 6 months
Secondary	IOL rotation	angle of rotation	postoperative 6 months