Astigmatism
Conditions
Brief summary
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.
Interventions
OTHERFemto arcs
Femtosecond laser-assisted arcuate corneal relaxing incisions (AK) will be performed to correct astigmatism.
DEVICELight Adjustable Lens (LAL)
The LAL is intended to replace the natural lens at time of lens removal.
Sponsors
LensAR Incorporated
Center For Sight
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must be aged ≥ 21 years at the time of eligibility visit. 2. 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). 3. Subject must be able and willing to comply with the study examination procedures. 4. Astigmatic treatment must require paired arcs \<45mm in length. 5. Subject must be willing to complete the approved informed consent form. 6. Subject must have elected to undergo lens extraction and Light Adjustable Lens (LAL) implantation. 7. Subject must be willing and able to return for scheduled pre-op and follow-up examinations. 8. Subject must have central 7 mm of clear cornea without vascularization.
Exclusion criteria
1. Subject who has undergone previous corneal or intraocular surgery in the eye to be treated. 2. 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. 3. Subject with neuro-ophthalmic disease. 4. Diabetic or hypertensive subject with clinical evidence of retinal pathology that the investigator believes will significantly affect visual outcomes. 5. Subject with macular degenerative pathology identified at the preoperative visit that the investigator believes will significantly affect visual outcomes. 6. Subject with a history of steroid-responsive rise in intraocular pressure (IOP), preoperative IOP \>25 mmHg, or uncontrolled glaucoma in either eye. 7. Subject with known lens/zonular instability. 8. Subject who cannot achieve dilated pupillary diameter \> 6 mm. 9. Subject with abnormal corneal topography, including evidence of forme fruste keratoconus, keratoconus or pellucid marginal degeneration. 10. Subject with posterior segment disease or degeneration. 11. Subject with corneal disease or pathology that precludes an adequate view for imaging or transmission of laser wavelength of light. 12. Subject with known sensitivity to planned perioperative standard of care medications. 13. Subject participating in any other ophthalmic drug or device clinical trial during the time of this clinical assessment. 14. Subject with known sensitivity to planned assessment concomitant medications. 15. Subjects with severe dry eye syndrome (DES) or history of ocular inflammation that may impact visual outcomes. 16. Subject with irregular astigmatism in the eye to be treated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of LAL adjustments required to achieve the desired refraction | 8 weeks after last lock-in |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of eyes with residual refractive astigmatism ≤ 0.50 D | 8 weeks after last lock-in |
Countries
United States
Contacts
Primary ContactHelga P Sandoval
Outcome results
None listed