None listed
Conditions
Brief summary
Implantation of an intraocular lens (IOL) is a standard method of visual rehabilitation in pseudophakic eyes following cataract removal. Although modern IOLs can offer high quality vision at a selected distance, correction over a continuous range of viewing distance is challenging. Plethora of IOL designs, such as accommodating, multifocal and extended depth-of-focus (EDoF) IOLs, have been introduced in attempts to address the issue. To date, commercially available IOL designs are limited in their ability to provide clear vision over a range of focal distances without causing undesirable disturbances in vision– Some fail to offer adequate near vision and others have inherent design-related visual disturbances and dysphotopsia. RayOne EMV IOL is a non-diffractive Extended Depth of Field (EDoF) presbyopia correcting IOL using a non difractive technique based on enhancing and utilising the normal positive spherical aberration of the human optical system. The IOL is specifically designed to avoid the photopic symptoms associated with the diffractive and split refractive designs currently available. This study aims to investigate visual outcome and patient satisfaction after implantation of RayOne EMV EDoF IOL employing a monovision (-0.75 to -1.0D) strategy and compare the results from those using a standard RayOne aspheric IOL with the same Monovision approach. This will be a single centre randomised clinical trial. A total of 110 subjects with bilateral senile cataract will be recruited and randomised equally into two treatment arms. Four to six weeks and 12 to 16 weeks post-operative monocular and binocular visual acuities at distance, intermediate and near will be investigated as the primary outcome variables and compared between the two groups. Other outcome variables will include stereoacuity, contrast sensitivity, patient satisfaction and spectacle independence.
Interventions
Total 110 subjects (220 eyes) with bilateral senile cataract, otherwise normal eye, will be recruited and equally randomized into two groups:
Intervention group will receive bilateral implantation of RayOne EMV extended depth-of-focus intraocular lens (IOL). The dominant eye will be implanted with an emmetropic correction, and the non-dominant eye will be targeted for -0.75D to -1.0D post-operative refraction.
Two eye surgeries will be performed at least three weeks apart in both groups.
The su
Total 110 subjects (220 eyes) with bilateral senile cataract, otherwise normal eye, will be recruited and equally randomized into two groups: Intervention group will receive bilateral implantation of RayOne EMV extended depth-of-focus intraocular lens (IOL). The dominant eye will be implanted with an emmetropic correction, and the non-dominant eye will be targeted for -0.75D to -1.0D post-operative refraction. Two eye surgeries will be performed at least three weeks apart in both groups. The surgery will be performed by the principal investigator using a standard phacoemulsification cataract surgical procedure. Ocular biometry and IOL selection will follow the following procedures: Biometry measurement: Corneal curvature (Keratometry), axial length, corneal thickness, anterior chamber depth, lens thickness and vitreous chamber depth will be measured using IOL Master 500 (Carl Zeiss Meditec, Germany) at baseline visit. Three consecutive biometry will be performed; the most consistent values measurements as decided by the principal investigator after a careful inspection of the results, will be used for IOL calculation. Biometry will be repeated if needed as prompted by the investigator. IOL Power Calculation: The European Society of Cataract and Refractive Surgery (ESCRS) online IOL calculator will be used in IOL calculation with the biometry values decided by the principal investigator (preceding section). IOL Power Selection Spherical IOL will be implanted in the eyes with pre-operative corneal astigmatism of less than 0.75D as measured by IOL master. For the corneal astigmatism equal to or greater than 0.75D, implantation of toric IOL will be planned. The spherical equivalent (SE) power of the IOL producing post operative target refraction of emmetropia (closest to zero) will be selected for implantation for the dominant eye and myopia between -0.75D and -1.00D for the non-dominant eye.
Sponsors
Dr Graham Hay-Smith
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Age 45 years or over - Pre-operative vision 6/60 or better - Bilateral senile cataract - Willing and able to sign informed consent form
Exclusion criteria
• Axial length less than 22.0mm and more than 26.0mm • Corneal astigmatism greater than 2.50D • Previous cataract surgery - History of corneal refractive surgery - Glaucoma - Corneal disorders that might affect visual acuity and visual function - Previous intraocular surgery such as vitrectomy, iridectomy - Any retinal pathology affecting vision such as: History of amblyopia Anisometropia of more than 2.0D - Constant strabismus - Optic nerve and visual pathway pathology - Intellectual impairment
Outcome results
None listed