BridgeMD
Compares treatment options for Cataract Senile
Official title Extended Depth of Focus (EDF) Intraocular Lens (IOL) Versus Monofocal Intracoular Lens (IOL)
ClinicalTrials.gov ID: NCT07092020
What this study is testing
- What it's testing
- Extended depth of focus (EDF) intraocular lens (IOL) versus Monofocal intraocular lens (IOL)
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
- Patients of any gender, aged 18 years or older
- Patient with clinically significant bilateral age-related cataracts planned for phacoemulsification cataract extraction and eligible for implantation...
- Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D)
- Calculated lens power within the available range
- Clear intraocular media other than cataract
You likely can't join if
- Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)
- Endothelial cell count of less than 2000/mm2
- Acute, chronic, or uncontrolled systemic disease that could increase the operative risk or confound the outcome including but not limited to poorly...
- Ocular condition that may predispose patient to future complications, per investigator's medical judgement, including but not limited to severe dry...
- Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity or oedema as...
- Previous intraocular or corneal/refractive surgery that might confound the outcome of the investigation or increase the risk to the patient...
See the full eligibility criteria
- Patients of any gender, aged 18 years or older
- Patient with clinically significant bilateral age-related cataracts planned for phacoemulsification cataract extraction and eligible for implantation of a posterior chamber intraocular lens as determined by...
- Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D)
- Calculated lens power within the available range
- Clear intraocular media other than cataract
- Patient is willing and capable of providing informed consent
- Patient is willing and capable of complying with visits and procedures as defined by this protocol
- Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)
- Endothelial cell count of less than 2000/mm2
- Acute, chronic, or uncontrolled systemic disease that could increase the operative risk or confound the outcome including but not limited to poorly controlled diabetes mellitus, active cancer treatment, mental illness...
- Ocular condition that may predispose patient to future complications, per investigator's medical judgement, including but not limited to severe dry eye, anterior segment pathology, uncontrolled glaucoma, that would...
- Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity or oedema as per Investigator's medical judgement; conditions including but not...
- Previous intraocular or corneal/refractive surgery that might confound the outcome of the investigation or increase the risk to the patient (including corneal transplants, removal of pterygium, and LASIK, LASEK, PRK, RK...
- Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
- Patients with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders, optic nerve atrophy etc.) or any other pathologies of the eye that are predicted to result in a visual acuity...
- Current systemic or ocular pharmacotherapy that effects patients' vision with significant ocular side effects or any medications that could confound the outcome or increase subject risk
- Clinically significant gonioscopic abnormalities
- Amblyopia, strabismus, single eye status
- Rubella, congenital, traumatic or complicated cataracts
- History of or current anterior or posterior segment inflammation, including but not limited to iritis or uveitis
- Microphthalmos or macrophthalmos
- Pupil abnormalities (e.g. aniridia, abnormal shaped pupils, nonreactive pupils)
- Pseudoexfoliation
- Keratoconus or irregular astigmatism
- Inability to measure keratometry or biometry (including but not limited to cataract density, etc.)
- Pathologic miosis
- Pregnant, plan to become pregnant, lactating during the course of the investigation, or another condition with associated fluctuation of hormones that could lead to refractive changes
- Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
- Patients whose freedom is impaired by administrative or legal order
- Concurrent participation in another clinical investigation in the last 30 days.
The study team makes the final eligibility decision.
Where it's taking place
- Sofia, Bulgaria
- Stara Zagora, Bulgaria
- Havlíčkův Brod, Czechia
- Pardubice, Czechia
- Prague, Czechia
- Bucharest, Romania
- Sibiu, Romania
- Suceava, Romania
- Alicante, Spain
- Madrid, Spain
- Sant Cugat del Vallès, Spain
- Santiago de Compostela, Spain
- Valencia, Spain
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 Sofia, Bulgaria; Stara Zagora, Bulgaria; Havlíčkův Brod, Czechia; Pardubice, Czechia; Prague, Czechia; Bucharest, Romania and 7 more location(s). 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.