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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03364972
Other study ID # 232017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 6, 2018
Est. completion date August 1, 2019

Study information

Verified date August 2019
Source Guy's and St Thomas' NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a bilateral randomised controlled study to compare visual performance, refractive outcome, forward light scatter, patient satisfaction and objective measurement of glistenings following insertion of two monofocal, aspheric, hydrophobic acrylic intraocular lenses (IOLs). A new product is compared with an established one.


Recruitment information / eligibility

Status Completed
Enrollment 145
Est. completion date August 1, 2019
Est. primary completion date August 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- bilateral cataracts

- good visual potential

- ability to understand informed consent and objectives of the trial

- not-pregnant

- not breast feeding

- no previous eye surgery

- corneal astigmatism less than 1 diopter in both eyes

Exclusion Criteria:

- age-related macula degeneration

- glaucoma

- previous retinal vascular disorders

- previous retinal detachment or tear

- any neuro-ophthalmological condition

- any inherited retinal disorder or pathology

- previous strabismus surgery or record of amblyopia

- previous transient ischaemic attacks, cerebrovascular events or other vaso-occlusive disease

- already enrolled in another study

- Exclusion criteria relate to clinical contraindications for Femtosecond Laser Assisted Cataract Surgery, such as:

- Significant corneal opacities

- Small pupils following pharmacological dilatation

- Patients unable to lie sufficiently flat so as to be positioned underneath the laser machine

Study Design


Intervention

Device:
Cataract surgery
Conventional small-incision phacoemulsification cataract surgery with insertion of intraocular lens implant

Locations

Country Name City State
United Kingdom St Thomas' Hospital NHS Trust London

Sponsors (3)

Lead Sponsor Collaborator
Guy's and St Thomas' NHS Foundation Trust City, University of London, King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Forward light scatter Intraocular (forward) light scatter is measured with a specifically devised computerised vision test. It is represented by straylight parameter, Log(s), on a logarithmic scale from 0 to 1.5. The lower the value (i.e. closer to 0), the better the outcome. 13 months
Other Contrast sensitivity Visual acuity (LogMAR scale: total range -0.2 to 1.0 in 0.02 steps) measured at different contrasts with a computerized contrast sensitivity chart. Negative values, or values closer to 0, represent better outcome. 13 months
Other Patient satisfaction Validated patient satisfaction questionnaire. We use specially designed and validated conversion tables to convert raw scores from questionnaires to Rasch calibrated measures. 13 months
Other Self-reported health Validated self-reported health questionnaire. We use a vertical Visual Analogue Scale (VAS) to record patients' self-reported health on a scale from 0-100 (values closer or equal to 100 represent better outcome). 13 months
Primary Visual acuity As measured by conventional LogMAR visual acuity charts 13 months
Secondary Incidence of intraocular lens glistenings Incidence of presence of intraocular lens glistenings in each study arm 13 months
Secondary Severity of intraocular lens glistenings Number of vacuoles per square millimetre 13 months
Secondary Refraction (i.e. glasses prescription) In conventional sphere/cylinder dioptre scales: total range -40 to +40, in 0.25 steps. Higher values represent worse outcome. Values closer to 0 (zero) represent better outcome 13 months
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