BridgeMD
New treatment option for Cataract
Official title Odyssey Evaluation in Post LASIK Patients
ClinicalTrials.gov ID: NCT07260695
What this study is testing
- What it's testing
- This prospective study evaluates the visual and refractive outcomes of the TECNIS Odyssey intraocular lens (IOL) implanted in patients with a history of myopic LASIK. Given the unique optical challenges of post-LASIK eyes, including altered corneal curvature and higher-order aberrations, the study aims to assess the IOL's performance in terms of distance, intermediate, and near vision, and patient satisfaction.
- 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 50 and older
You may be able to join if
- people MUST fulfill the following conditions to qualify for enrollment into the trial
- Age: 50 years and older.
- Gender: Males and Females.
- Bilateral cataracts
- Bilateral implantation of Odyssey IOLs (toric and non-toric)
You likely can't join if
- people with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.
- Established ocular pathology, including: glaucoma (except glaucoma suspects), uveitis, and clinically-significant retinal pathology affecting the...
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
- Clinically significant corneal dystrophy.
See the full eligibility criteria
- people MUST fulfill the following conditions to qualify for enrollment into the trial
- Age: 50 years and older.
- Gender: Males and Females.
- Bilateral cataracts
- Bilateral implantation of Odyssey IOLs (toric and non-toric)
- Scheduled to undergo standard cataract surgery in both eyes, within 1 to 30 days between surgeries.
- Willing and able to provide written informed consent for participation in the study.
- Willing and able to comply with scheduled visits and study examination procedures.
- Postoperative best corrected visual acuity of 0.2 logMAR (20/32 Snellen) or better in each eye.
- people with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.
- Established ocular pathology, including: glaucoma (except glaucoma suspects), uveitis, and clinically-significant retinal pathology affecting the macula (with visual acuity worse than 20/25) and/or any other ocular...
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
- Clinically significant corneal dystrophy.
- Contact lens use during the active treatment portion of the trial.
- Irregular astigmatism.
- Corneal irregularities potentially affecting visual acuity (i.e., keratoconus, corneal opacities
- History of chronic intraocular inflammation.
- History of retinal detachment.
- Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
- Previous intraocular surgery.
- Previous keratoplasty
- Previous refractive surgery other than myopic LASIK or PRK (i.e., radial keratotomy, hyperopic LASIK, etc)
- Severe dry eye.
- Pupil abnormalities.
- Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e., LASIK).
- Any clinically significant, serious, or severe medical or psychiatric condition that may interfere with the interpretation of study results.
- Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
- Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- Abnormal iris The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates the patient is unsuitable for the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Venice, Florida, United States
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, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Venice, Florida, United States. 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.