Clinical trial NCT02264457: A Intra-patient Comparison of Closed Loop and Plate Haptic Toric Intraocular Lenses
Official title: A Randomised Intra-patient Comparison of Closed Loop and Plate Haptic Toric, Aspheric, Aberration Neutral, Hydrophilic Acrylic Intraocular Lenses in Patients With Bilateral Astigmatism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cataract
Keywords: Lenses, Intraocular
Lead sponsor: University of Plymouth
Sponsor class: OTHER
Collaborators: name: BMI Southend Hospital
First posted: 2014-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During cataract surgery an artificial lens is implanted in the eye. These artificial lenses are called intraocular lenses (IOLs) and there are many different types of IOL designs. Your eyes have astigmatism, which is a normal and common characteristic of the eye. If left uncorrected the astigmatism would mean that you would need to wear spectacles for viewing distance objects. New IOL designs called toric IOLs help to correct the astigmatism to improve your vision after cataract surgery. This study has been designed to look at how well a toric IOL corrects this astigmatism so that you do not need to wear spectacles for viewing distance objects. There are many designs of these toric IOLs and for this study we are looking to compare two different designs of toric IOLs by putting one lens in your right eye and a different type of lens in your left eye. Both lenses are commercially available and are commonly implanted IOLs. Using new non-invasive methods we hope to be able to better judge the visual performance of these lenses and the ability of these lenses to correct astigmatism. In addition the study will involve imaging and examining the IOLs to determine the prevalence of any post-operative complications.


Eligibility criteria: Inclusion Criteria:

* Age 50-75 years, bilateral significant corneal astigmatism \>1.50D.
* Requiring a Toric IOL within the following power range:
* Sphere +6.00D to +30.00D
* Cylinder +1.00D to +6.00D

Exclusion Criteria:

* Amblyopia,
* predicted bilateral post-op corneal astigmatism of \<1.50D,
* irregular astigmatism,
* dilated pupil size smaller than 5mm,
* macular pathology,
* glaucoma,
* retinal disease,
* corneal disease,
* abnormal iris,
* pupil deformation and
* any previous corneal or intraocular surgery.

Primary outcomes:
measure: Best-corrected visual acuity
timeFrame: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months
Secondary outcomes:
measure: Manifest refraction
timeFrame: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)
measure: Rotational stability
timeFrame: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)
measure: IOL centration
timeFrame: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)
measure: Prevalence of posterior capsular Opacification
timeFrame: visit 4 (3-4 months)
Other outcomes:
Locations:
city: Westcliff on Sea
country: United Kingdom
facility: BMI Southend Private Hospital
state: Essex
Study officials:
affiliation: Plymouth University
name: Phillip J Buckhurst, PhD
role: PRINCIPAL_INVESTIGATOR
References: