Visual Performance With a Hydrophobic Aspheric Monofocal IOL

University of Plymouth

Status and phase: Unknown; Phase 4

Conditions: Cataract

Treatments: Device: EyeCee One intraocular lens

Study type: Interventional

Funder types: Other

Identifiers

NCT03819582

17/WM/0181

Details and patient eligibility

About

Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide excellent distance vision, however spectacles are required for reading and intermediate distance tasks. Monofocal Intraocular lenses are the mainstay of cataract surgery, but with advancing technologies and a wider selection of lenses available, demand for improved outcomes, improved lens design and ease of surgical implantation have increased. The purpose of this study is to assess the visual performance of the EyeCee One monofocal intraocular lens. In addition an assessment of the ease of insertion by the surgeon will be quantified.

Full description

Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide excellent distance vision, however spectacles are required for reading and intermediate distance tasks. There are many different designs of monofocal IOLs, all with their own unique optical properties, however there is little evidence to support which optical design provides the best visual outcome. This research project allows us to assess the visual outcomes of a specific monofocal IOL. It also allows us to assess the ease of use of the lens to the surgeon.

Each subject will be evaluated at two visits following IOL implantation; visit 1 (1 month post implantation), Visit 2 (3 months post implantation).

At both post-operative visits the patient will undergo:

Refraction Uncorrected and best corrected distance and near visual acuity measurement Optical biometry to assess ELP Slit lamp biomicroscopy to assess for post-operative complications

At the time of surgery, the ophthalmic surgeon will complete a questionnaire, detailing lens insertion time and ease of use.

Enrollment: 100 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Clinically significant Cataract requiring cataract surgery

Exclusion criteria

• Amblyopia
• Corneal astigmatism of >1.00D
• Dilated pupil size smaller than 5mm
• Macular pathology
• Glaucoma
• Retinal disease
• Corneal disease
• Abnormal iris
• Pupil deformation
• Any previous corneal or intraocular surgery
• Any patient who had surgical complications will also be excluded from participation in the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Intraocular lens

Experimental group

Description:

Subjects implanted with the EyeCee One Intraocular lens

Treatment:

Device: EyeCee One intraocular lens