AstigmatismPhase 4NCT07140653
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
A Phase 4 study testing Femto arcs and Light Adjustable Lens (LAL) in people with Astigmatism, run by Center For Sight at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Astigmatism
- What is being tested?
- Femto arcs and Light Adjustable Lens (LAL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Sep 2025to 2 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
- Subjects 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, 29464
Helga P Sandoval
- Recruiting
Center For Sight
Venice, Florida, 34285
Gina Thomas, 941-263-4784, gthomas@centerforsight.net
About this study
Official title: Evaluation of Arcuate Incisions for Correcting Pre-Existing Corneal Astigmatism in Combination With the Light Adjustable Lens for Cataract and Refractive Lens Exchange Surgery
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.
- Conditions
- Astigmatism
- Being tested
- Femto arcs, Light Adjustable Lens (LAL)
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femto arcsOther
Femtosecond laser-assisted arcuate corneal relaxing incisions (AK) will be performed to correct astigmatism.
Light Adjustable Lens (LAL)Device
The LAL is intended to replace the natural lens at time of lens removal.
| Study group | Role | What they receive |
|---|---|---|
| Femto arcs + LAL | Other | Not described Receives: Other: Femto arcs; Device: Light Adjustable Lens (LAL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of LAL adjustments required to achieve the desired refraction
Measured: 8 weeks after last lock-in
Secondary outcomes (1)
Percentage of eyes with residual refractive astigmatism ≤ 0.50 D
Measured: 8 weeks after last lock-in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2025
- Study start2 Sep 2025
- Primary completion2 Jan 2027 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center For Sight
- Sponsor type
- University, hospital or other
- Collaborators
- LensAR Incorporated
- Responsible party
- Sponsor
- Investigators
- Priya Mathews, MD, Principal investigator, Center For Sight - Clinical Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140653
- Sponsor's protocol ID
- CFS 25-003
- Status last verified
- Oct 2026
- First submitted
- 22 Aug 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Arcuate Incisions for Correcting Pre-Existing Corneal Astigmatism in Combination With the Light Adjustable Lens for Cataract and Refractive Lens Exchange Surgery
- ClinicalTrials.gov ID
- NCT07140653
- Acronym / sponsor ID
- CFS 25-003
- Conditions
- Astigmatism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Center For SightUniversity, hospital or other
- Collaborators
- LensAR Incorporated
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 25 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femto arcs + LAL | Other | Other: Femto arcs, Device: Light Adjustable Lens (LAL) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femto arcsFemtosecond laser-assisted arcuate corneal relaxing incisions (AK) will be performed to correct astigmatism. | Other | Femto arcs + LAL |
| Light Adjustable Lens (LAL)The LAL is intended to replace the natural lens at time of lens removal. | Device | Femto arcs + LAL |
Primary outcome
Number of LAL adjustments required to achieve the desired refraction
Time frame: 8 weeks after last lock-in
1 secondary outcome
Percentage of eyes with residual refractive astigmatism ≤ 0.50 D
Time frame: 8 weeks after last lock-in
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Astigmatism
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Priya Mathews, MD principal investigator
Center For Sight - Clinical Studies
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Femto arcs and Light Adjustable Lens (LAL) in people with Astigmatism, run by Center For Sight at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helga P Sandoval (8438813937, hps@cepmd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of LAL adjustments required to achieve the desired refraction (time frame: 8 weeks after last lock-in). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.