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New treatment option for Astigmatism
Official title Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
ClinicalTrials.gov ID: NCT07140653
What this study is testing
- What it's testing
- This study aims to evaluate the safety and effectiveness of femtosecond laser arcuate corneal relaxing incisions (AK) combined with Light Adjustable Lens (LAL) implantation for correcting pre-existing corneal astigmatism in patients undergoing cataract or refractive lens exchange surgery. Postoperative assessments will focus on residual refractive astigmatism, visual outcomes, patient satisfaction, and the incidence of adverse events.
- 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 21 and older
You may be able to join if
- Subject must be aged ≥ 21 years at the time of eligibility visit.
- Subject must have a vector difference of 0.50 D or less in magnitude of pre-operative anterior corneal astigmatism as measured by the Pentacam AXL...
- Subject must be able and willing to comply with the study examination procedures.
- Astigmatic treatment must require paired arcs \<45mm in length.
- Subject must be willing to complete the approved informed consent form.
You likely can't join if
- Subject who has undergone previous corneal or intraocular surgery in the eye to be treated.
- Subject with a history, signs or symptoms of ocular disease or atypical findings that would be contraindicated under standard of care for lens...
- Subject with neuro-ophthalmic disease.
- Diabetic or hypertensive subject with clinical evidence of retinal pathology that the investigator believes will significantly affect visual outcomes.
- Subject with macular degenerative pathology identified at the preoperative visit that the investigator believes will significantly affect visual...
- Subject with a history of steroid-responsive rise in intraocular pressure (IOP), preoperative IOP \>25 mmHg, or uncontrolled glaucoma in either eye.
See the full eligibility criteria
- Subject must be aged ≥ 21 years at the time of eligibility visit.
- Subject must have a vector difference of 0.50 D or less in magnitude of pre-operative anterior corneal astigmatism as measured by the Pentacam AXL and the Zeiss IOLMaster 700 (Carl Zeiss Meditec).
- Subject must be able and willing to comply with the study examination procedures.
- Astigmatic treatment must require paired arcs \<45mm in length.
- Subject must be willing to complete the approved informed consent form.
- Subject must have elected to undergo lens extraction and Light Adjustable Lens (LAL) implantation.
- Subject must be willing and able to return for scheduled pre-op and follow-up examinations.
- Subject must have central 7 mm of clear cornea without vascularization.
- Subject who has undergone previous corneal or intraocular surgery in the eye to be treated.
- Subject with a history, signs or symptoms of ocular disease or atypical findings that would be contraindicated under standard of care for lens extraction surgery.
- Subject with neuro-ophthalmic disease.
- Diabetic or hypertensive subject with clinical evidence of retinal pathology that the investigator believes will significantly affect visual outcomes.
- Subject with macular degenerative pathology identified at the preoperative visit that the investigator believes will significantly affect visual outcomes.
- Subject with a history of steroid-responsive rise in intraocular pressure (IOP), preoperative IOP \>25 mmHg, or uncontrolled glaucoma in either eye.
- Subject with known lens/zonular instability.
- Subject who cannot achieve dilated pupillary diameter \> 6 mm.
- Subject with abnormal corneal topography, including evidence of forme fruste keratoconus, keratoconus or pellucid marginal degeneration.
- Subject with posterior segment disease or degeneration.
- Subject with corneal disease or pathology that precludes an adequate view for imaging or transmission of laser wavelength of light.
- Subject with known sensitivity to planned perioperative standard of care medications.
- Subject participating in any other ophthalmic drug or device clinical trial during the time of this clinical assessment.
- Subject with known sensitivity to planned assessment concomitant medications.
- people with severe dry eye syndrome (DES) or history of ocular inflammation that may impact visual outcomes.
- Subject with irregular astigmatism in the eye to be treated.
The study team makes the final eligibility decision.
Where it's taking place
- Venice, Florida, United States
- Mt. Pleasant, South Carolina, 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, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Venice, Florida, United States; Mt. Pleasant, South Carolina, 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.