BridgeMD
New treatment option for Cataract
Official title Toric Performance And Constant Evaluation
ClinicalTrials.gov ID: NCT07471295
What this study is testing
- What it's testing
- The main purpose of this investigation is to support safety and performance assessment of the investigational device with a focus on optimizing the IOL constants based on refractive outcomes.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged 18 years or older;
- Patients willing, able, and with sufficient cognitive awareness to comply with examination procedures and schedule for follow-up visits;
- Patients with clinically significant age-related cataract (cataract grades of 1, 2, 3 on the LOCSIII scale, but otherwise healthy, requiring surgical...
- Patients with existing regular corneal astigmatism of minimum 0.75 D in at least the first eye to be operated.
- Signed informed consent form;
You likely can't join if
- Previous intraocular or corneal surgery in either eye that might confound the outcome of the study or increase the risk to the subject;
- Keratometric astigmatism (assessed by IOL Master) of minimum 0.75 D in the first eye
- Traumatic cataract;
- Pregnancy or lactation;
- Concurrent participation in another drug or device investigation within the last 30 days;
- Irregular astigmatism;
See the full eligibility criteria
- Aged 18 years or older;
- Patients willing, able, and with sufficient cognitive awareness to comply with examination procedures and schedule for follow-up visits;
- Patients with clinically significant age-related cataract (cataract grades of 1, 2, 3 on the LOCSIII scale, but otherwise healthy, requiring surgical treatment, and scheduled for unilateral or bilateral...
- Patients with existing regular corneal astigmatism of minimum 0.75 D in at least the first eye to be operated.
- Signed informed consent form;
- Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment;
- Calculated IOL power within the range of the investigational IOL; SE +18.0 D to +28.0 D (0.5 D Steps), and between a Cylinder range of +1.0 D to +2.5 D (0.5 D Steps);
- Dilated pupil size large enough to visualize TIOL axis markings postoperatively; at least 5.5mm;
- Clear intraocular media other than cataract.
- Previous intraocular or corneal surgery in either eye that might confound the outcome of the study or increase the risk to the subject;
- Keratometric astigmatism (assessed by IOL Master) of minimum 0.75 D in the first eye
- Traumatic cataract;
- Pregnancy or lactation;
- Concurrent participation in another drug or device investigation within the last 30 days;
- Irregular astigmatism;
- Instability of keratometry or biometry measurements;
- people wearing contact lenses as standard vision aid;
- Abnormal pupil;
- Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.);
- History of concurrent intraocular inflammation;
- Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or clinically significant corneal membrane dystrophies);
- History of any clinically significant retinal or ocular pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy...
- Pseudoexfoliation syndrome (according to investigator judgement);
- Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment;
- All kind of infections (acute ocular disease, external / internal infection, systemic infection);
- Monophthalmic patient;
- Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus, Parkinson disease
- Patient expected to require retinal laser treatment before the end of the last follow-up examination;
- Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination;
- Patients who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than Nd:YAG capsulotomy)
- In case of both eyes included in this trial: Patients who need to undergo surgery on both eyes on the same day
The study team makes the final eligibility decision.
Where it's taking place
- Prague, Prague, Czechia
- Prague, Czechia
- Heidelberg, Germany
- Rheine, Germany
- Alicante, Spain
- Ayr, Ayrshire, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Prague, Prague, Czechia; Prague, Czechia; Heidelberg, Germany; Rheine, Germany; Alicante, Spain; Ayr, Ayrshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.