Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
ConditionAstigmatism
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21+
SponsorCenter For Sight
About this trial
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. Arcuate keratotomy and toric IOLs are well-established methods for astigmatism correction, and this study will compare their combined effectiveness using advanced femtosecond laser technology.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Femto arcs
Other interventionFemtosecond laser-assisted arcuate corneal relaxing incisions (AK) will be performed to correct astigmatism.
Light Adjustable Lens (LAL)
DeviceThe LAL is intended to replace the natural lens at time of lens removal.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Femto arcs + LALOther 2 interventions
Trial outcomes
Primary outcomes
1
Number of LAL adjustments required to achieve the desired refraction
Time frame
8 weeks after last lock-inSecondary outcomes
1
Percentage of eyes with residual refractive astigmatism ≤ 0.50 D
Time frame
8 weeks after last lock-inSponsors and contacts
Click on the lead sponsor to view all of their trials.
Center For Sight
Lead sponsor
LensAR Incorporated
Collaborator
Source ClinicalTrials.gov