BridgeMD
New treatment option for Cataract
Official title Clinical Application Comparison of Two Femtosecond Laser Systems
ClinicalTrials.gov ID: NCT06754358
What this study is testing
- What it's testing
- The goal of this clinical trial is to compare the perioperative parameters of femtosecond laser-assisted cataract surgery (FLACS) using two laser systems. Participants will: Undergo FLACS using LenSx or Z8 femtosecond laser system Visit the clinic before the operation and 1 day, 1 week, and 1 month after the operation for checkups and tests Complete clinical measurements and dry eye questionnaires
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Chinese Han patients aged 40 years or older
- clinical diagnosis of age-related cataracts;
- underwent FLACS with insertion of a posterior chamber IOL for the first eye.
You likely can't join if
- coexisting macular pathologies such as epiretinal membrane, macular hole or edema, or age-related macular degeneration. Patients with OCT scans of...
- preoperative flare of more than 15ph/ms11, ECD\<2000cells/mm2 or any other corneal pathologies;
- coexisting serious ocular diseases including uveitis, uncontrolled glaucoma, optic atrophy , amblyopia, retinopathies, or inflammatory pathology of...
- history of intraocular trauma, surgery, or retinal laser procedures;
- usage of systemic or topical steroids or NSAIDs within one month prior to surgery;
- patients with diabetes or any other systemic diseases that might confound the results or increase the risk for postoperative inflammation;
See the full eligibility criteria
- Chinese Han patients aged 40 years or older
- clinical diagnosis of age-related cataracts;
- underwent FLACS with insertion of a posterior chamber IOL for the first eye.
- coexisting macular pathologies such as epiretinal membrane, macular hole or edema, or age-related macular degeneration. Patients with OCT scans of poor quality were excluded;
- preoperative flare of more than 15ph/ms11, ECD\<2000cells/mm2 or any other corneal pathologies;
- coexisting serious ocular diseases including uveitis, uncontrolled glaucoma, optic atrophy , amblyopia, retinopathies, or inflammatory pathology of the eye;
- history of intraocular trauma, surgery, or retinal laser procedures;
- usage of systemic or topical steroids or NSAIDs within one month prior to surgery;
- patients with diabetes or any other systemic diseases that might confound the results or increase the risk for postoperative inflammation;
- intraoperative complications such as capsule tear, hyphema, vitreous loss, iris manipulation, or miosis after laser pre treatment requiring intracameral injection of epinephrine;
- ocular conditions contraindicating FLACS including poorly dilated pupils (\<5.0mm), narrow palpebral fissure, small hyperopic eyes with steep cornea (difficult to achieve suction), severe conjunctival chalasis...
- potentially pregnant women;
- known sensitivity to concomitant medications used during perioperative period, participation in other clinical trial during the time of visit, or poor cooperation in diagnostic tests or non-compliance at follow-up.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
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, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
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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.