Vision and Balance Changes After Bilateral Implantation of Toric IOLs (NCT05629078) | Clinical Trial Compass
UnknownNot Applicable
Vision and Balance Changes After Bilateral Implantation of Toric IOLs
United Kingdom140 participantsStarted 2024-01-12
Plain-language summary
Cataracts are the major cause of blindness in the world. Cataract surgery, being the most performed surgery in the world today, provide correction by extracting the natural lens from its capsular bag and replaced by an artificial intraocular lens (IOL) implantation. In the UK, almost all patients undergoing cataract surgery by the NHS are given monofocal intraocular lenses (IOLs) which do not correct corneal astigmatic error. It is estimated that around 20% of the population has over 1.50DC of corneal astigmatism. Uncorrected astigmatism not only increase spectacle dependency and reduce quality of life post surgically, but it also adversely affects the overall economic costs. Specialised toric IOLs offer the opportunity to correct pre-existing corneal astigmatism. Previous work has shown a link between reduced vision and balance or mobility. Full correction of refractive error may have greater impact on lifestyle than previously thought.
Who can participate
Age range
50 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* bilateral significant corneal astigmatism \>1.0D
* on waiting list for bilateral cataract surgery in NHS
Exclusion Criteria:
* pre-existing eye pathology which may be aggravated by intraocular implant
* previous intraocular/ corneal surgery
* History of uveitis, glaucoma, proliferative diabetic retinopathy or IDDM, pseudoexfoliation, macular degeneration that may affect potential best corrected visual acuity of 20/40 or better
* Micropthalmia
* corneal decompensation or endothelial insufficiency
* pars planitis
* high myopia
* participants using a systematic medication that is known to cause ocular side effects
* participated in a concurrent clinical trial or have participated in an opthalmology clinical trial within the last 30 days
* unable or not willing to cooperate for the follow up period
* pregnant women
* unable to give informed consent
* unable to walk with or without walking aids independently for at least 20m
* unable to walk up/down stairs independently using aids or handrail
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Jerk from the centre of mass Visit 1
Timeframe: Baseline assessment will be carried out at study visit 1 before the cataract surgery
2
Jerk from the centre of mass Visit 2
Timeframe: First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery
3
Jerk from the centre of mass Visit 3
Timeframe: Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery