Clinical trial NCT03819582: Visual Performance With a Hydrophobic Aspheric Monofocal IOL
Official title: Visual Performance Following Implantation of a Hydrophobic Aspheric Monofocal Intraocular Lens
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cataract
Lead sponsor: University of Plymouth
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual acuity early post operative
timeFrame: 1 month post operatively
measure: Visual acuity after 3 months post operatively
timeFrame: 3 months post operatively
Secondary outcomes:
measure: Ease of use to surgeons
timeFrame: During surgery
Other outcomes:
Locations:
city: Westcliff-on-Sea
country: United Kingdom
facility: BMI Southend Hospital
state: Essex
Study officials:
References: