Corneal AstigmatismNCT07081919
Effectiveness, Stability and Influence Factors of Femtosecond Laser Assisted Cataract Surgery
An observational study of Corneal Astigmatism and Cataract, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
What is this study about? This study looks at whether a laser procedure called femtosecond laser-assisted arcuate keratotomy (FSAK) helps people with both cataracts and mild astigmatism see more clearly after cataract surgery. Astigmatism causes blurry vision because the front of the eye (cornea) is curved unevenly. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Corneal Astigmatism, Cataract
- What is being tested?
- femtosecond laser-assisted arcuate keratotomy (FSAK) combined with standard cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2025to 22 Apr 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with regular corneal astigmatism of 0.75-2.0 D who plan to undergo cataract surgery. Aged between 20 and 80 years old.
Who may be able to join
- Age: 20-80 years
- Age-related cataracts
- Regular corneal astigmatism (0.75-2.0 diopters) confirmed by Pentacam/IOLMaster 700
- Surgical Plan: Scheduled for femtosecond laser-assisted cataract surgery
- Central corneal thickness ≥500 µm
- Endothelial cell count ≥2,000 cells/mm²
- Best-corrected visual acuity (BCVA) improvable to ≥20/40
Who cannot join
- Prior corneal refractive surgery (e.g., LASIK, PRK)
- Intraocular surgery (e.g., glaucoma filtering surgery)
- Irregular astigmatism (keratoconus, scarring, post-traumatic distortion)
- Active ocular inflammation or infection
- Corneal endothelial disease (e.g., Fuchs' dystrophy)
- Severe dry eye (Schirmer test ≤5 mm/5 min)
Show all 13Show fewer
- Uncontrolled glaucoma (IOP >21 mmHg on medication)
- Macular pathology (e.g., AMD, DME affecting visual potential)
- Amblyopia
- Autoimmune diseases affecting cornea (e.g., rheumatoid arthritis, Sjögren syndrome)
- Diabetes mellitus with retinopathy
- Pregnancy/Lactation
- Inability to complete 5-year follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eye and Ear, Nose, and Throat Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
Jin Yang, PhD, 13671632525, jin_er76@hotmail.com
About this study
What is this study about? This study looks at whether a laser procedure called femtosecond laser-assisted arcuate keratotomy (FSAK) helps people with both cataracts and mild astigmatism see more clearly after cataract surgery. Astigmatism causes blurry vision because the front of the eye (cornea) is curved unevenly. The FSAK procedure uses a computer-guided laser to make tiny, precise cuts in the cornea during cataract surgery to fix this curve. the investigators want to see if this improves vision long-term (up to 5 years) and what factors affect how the investigatorsll it works.
Who can join? the investigators are looking for adults aged 20-80 years who:
Read more
Have cataracts and mild-to-moderate astigmatism (0.75-2.0 diopters) Plan to have cataract surgery Have not had prior eye surgeries (like LASIK) Do not have severe dry eye or other eye diseases (like glaucoma or retina problems) What will happen in the study?
Surgery: Participants will have cataract surgery combined with the FSAK procedure. The surgeon uses a laser to make tiny curved cuts in the cornea to reshape it.
Follow-up visits: Participants will have regular eye check-ups for 5 years after surgery. These include:
Vision tests (reading eye charts) Measurements of the eye's shape using painless imaging machines Questionnaires about vision quality and daily activities Time commitment: Visits happen at 1 the investigatorsek, 1 month, 3 months, 6 months, 1 year, 2 years, and 5 years after surgery. Each visit takes about 1-2 hours.
Why is this study important? FSAK may help people with astigmatism see clearly after cataract surgery without needing glasses as often. By tracking results for 5 years, the investigators'll learn how long the benefits last and who benefits most. This could help doctors better personalize treatment in the future.
Who is running the study? Eye doctors at Fudan University Eye \& ENT Hospital (Shanghai) and Shanghai Peace Eye Hospital. About 105 people will take part.
Read the detailed description
Study Description for General Audience
What's the problem? Many people with cataracts also have an irregularly curved front surface of the eye (called astigmatism). After cataract surgery, this astigmatism can still cause blurry or distorted vision, making everyday tasks like reading or driving difficult. While glasses or special lenses can help, many hope to reduce their dependence on them after surgery.
What's being tested?
This study evaluates a laser procedure called Femtosecond Laser-Assisted Arcuate Keratotomy (FSAK). During cataract surgery:
A computer-guided laser makes tiny, curved incisions in the cornea (the eye's clear front window).
These precise incisions gently reshape the cornea to improve its natural curve. Think of it like a sculptor smoothing uneven surfaces-but using light-speed technology.
Why is this study unique?
While FSAK isn't brand new, the investigators lack long-term data on:
How the investigatorsll it holds up over 5+ years. Which factors predict success (e.g., does participantsr eye's shape or pressure affect results?).
the investigators're following participants for 5 years to ansthe investigatorsr these questions-far longer than most existing studies.
What will participants experience?
Surgery: FSAK is combined with standard cataract removal. The laser step adds only minutes.
Follow-ups: Painless check-ups at 1 the investigatorsek, 1 month, 3 months, 6 months, 1 year, 2 years, and 5 years after surgery. These involve:
Reading eye charts. Quick scans to map the eye's surface. Short questionnaires about vision quality (e.g., glare at night or reading small print).
Why does this matter?
If successful, FSAK could:
- Help people see clearly longer after cataract surgery.
- Reduce the need for glasses or contacts.
- Give doctors better tools to personalize treatment.
Who's involved?
Led by eye specialists at Fudan University Eye \& ENT Hospital and Shanghai Peace Eye Hospital.
- Conditions
- Corneal Astigmatism, Cataract
- Being tested
- femtosecond laser-assisted arcuate keratotomy (FSAK) combined with standard cataract surgery
- Keywords
- femtosecond laser-assisted arcuate keratotomy, cataract surgery, corneal astigmtism, astigmatism treatment stability, predictors of surgical outcomes
- Medical subject headings
- Astigmatism, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
femtosecond laser-assisted arcuate keratotomy (FSAK) combined with standard cataract surgeryProcedure or surgery
- 5-year follow-up assessing stability of astigmatism correction. Most FSAK studies track ≤2 years. This addresses critical evidence gaps in durability
- Combines topographic data with patient-reported visual function (VF-14/QoV questionnaires at all visits. Links anatomical changes to real-world visual experiences
| Study group | Role | What they receive |
|---|---|---|
| FSAK with Cataract Surgery | Participants in this group undergo femtosecond laser-assisted arcuate keratotomy (FSAK) combined with standard cataract surgery Receives: Procedure: femtosecond laser-assisted arcuate keratotomy (FSAK) combined with standard cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in corneal astigmatism magnitude (diopters) from baseline
Measured: Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively
Secondary outcomes (6)
Visual Acuity-UCVA
Uncorrected Distance Visual Acuity (UDVA) at 5m (logMAR)
Measured: Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively
Visual acuity-BCVA
Best-Corrected Visual Acuity (BCVA) at 5m (logMAR)
Measured: Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively
Manifest refraction spherical equivalent (MRSE) in Diopter (D)
Measured: Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively
Corneal Topography
Corneal Topography assesses corneal curvature, with data collected using the Pentacam instrument and IOL Master. The measured outcome reflects the corneal's refractive power and shape characteristics. Corneal curvature is reported in diopters (D) , a standard unit for quantifying refractive power in ophthalmic measurements.
Measured: Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively
Objective Optical Quality
Objective visual quality is evaluated by measuring Total ocular higher - order aberrations (HOAs, unit: µm) and Strehl ratio (SR) using the iTrace instrument. Total ocular higher - order aberrations reflect the deviation of the eye's optical system from an ideal state, where higher values generally indicate greater optical imperfections that may disrupt visual clarity. The Strehl ratio, on the other hand, quantifies the quality of optical imaging; a higher SR (ranging from 0 to 1, with 1 representing ideal optical quality) signifies better visual quality, as it relates to the concentration of light in the retinal image. These metrics, derived from iTrace measurements, provide objective assessments of how well the eye processes visual input, crucial for evaluating surgical outcomes (e.g., cataract or refractive surgery) and ocular health.
Measured: Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively
Patient-Reported Outcomes
bjective visual quality can be assessed with the Visual Function-14 (VF-14) questionnaire, which evaluates 14 vision-dependent daily activities. Patients self-rate their functional limitations, with scores ranging from 0 (worst) to 100 (best), where higher scores indicate better visual function. It is administered preoperatively and 3 months postoperatively to measure changes, with a minimal clinically important difference of 15.57, meaning a score change exceeding this value signifies a meaningful improvement The DOI of reference for visual function questionnaire is 10.1016/j.ophtha.2010.04.009.
Measured: Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start22 Apr 2025
- Primary completion22 Apr 2030 (estimated)
- Study completion22 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal AstigmatismStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Yang, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081919
- Sponsor's protocol ID
- FSAK during cataract surgery
- Status last verified
- Jul 2025
- First submitted
- 1 Jun 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data contain sensitive biometric identifiers (e.g., corneal topography maps) that cannot be fully de-identified
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness, Stability and Influence Factors of Femtosecond Laser Assisted Cataract Surgery
- ClinicalTrials.gov ID
- NCT07081919
- Acronym / sponsor ID
- FSAK during cataract surgery
- Conditions
- Corneal Astigmatism, Cataract
- Keywords
- femtosecond laser-assisted arcuate keratotomy, cataract surgery, corneal astigmtism, astigmatism treatment stability, predictors of surgical outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 22 Apr 2030 (estimated)
- Study completion
- 22 Apr 2031 (estimated)
- First posted
- 23 Jul 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.
What is this study about? This study looks at whether a laser procedure called femtosecond laser-assisted arcuate keratotomy (FSAK) helps people with both cataracts and mild astigmatism see more clearly after cataract surgery. Astigmatism causes blurry vision because the front of the eye (cornea) is curved unevenly. The FSAK procedure uses a computer-guided laser to make tiny, precise cuts in the cornea during cataract surgery to fix this curve. the investigators want to see if this improves vision long-term (up to 5 years) and what factors affect how the investigatorsll it works.
Who can join? the investigators are looking for adults aged 20-80 years who:
Have cataracts and mild-to-moderate astigmatism (0.75-2.0 diopters) Plan to have cataract surgery Have not had prior eye surgeries (like LASIK) Do not have severe dry eye or other eye diseases (like glaucoma or retina problems) What will happen in the study?
Surgery: Participants will have cataract surgery combined with the FSAK procedure. The surgeon uses a laser to make tiny curved cuts in the cornea to reshape it.
Follow-up visits: Participants will have regular eye check-ups for 5 years after surgery. These include:
Vision tests (reading eye charts) Measurements of the eye's shape using painless imaging machines Questionnaires about vision quality and daily activities Time commitment: Visits happen at 1 the investigatorsek, 1 month, 3 months, 6 months, 1 year, 2 years, and 5 years after surgery. Each visit takes about 1-2 hours.
Why is this study important? FSAK may help people with astigmatism see clearly after cataract surgery without needing glasses as often. By tracking results for 5 years, the investigators'll learn how long the benefits last and who benefits most. This could help doctors better personalize treatment in the future.
Who is running the study? Eye doctors at Fudan University Eye \& ENT Hospital (Shanghai) and Shanghai Peace Eye Hospital. About 105 people will take part.
Detailed description
Study Description for General Audience
What's the problem? Many people with cataracts also have an irregularly curved front surface of the eye (called astigmatism). After cataract surgery, this astigmatism can still cause blurry or distorted vision, making everyday tasks like reading or driving difficult. While glasses or special lenses can help, many hope to reduce their dependence on them after surgery.
What's being tested?
This study evaluates a laser procedure called Femtosecond Laser-Assisted Arcuate Keratotomy (FSAK). During cataract surgery:
A computer-guided laser makes tiny, curved incisions in the cornea (the eye's clear front window).
These precise incisions gently reshape the cornea to improve its natural curve. Think of it like a sculptor smoothing uneven surfaces-but using light-speed technology.
Why is this study unique?
While FSAK isn't brand new, the investigators lack long-term data on:
How the investigatorsll it holds up over 5+ years. Which factors predict success (e.g., does participantsr eye's shape or pressure affect results?).
the investigators're following participants for 5 years to ansthe investigatorsr these questions-far longer than most existing studies.
What will participants experience?
Surgery: FSAK is combined with standard cataract removal. The laser step adds only minutes.
Follow-ups: Painless check-ups at 1 the investigatorsek, 1 month, 3 months, 6 months, 1 year, 2 years, and 5 years after surgery. These involve:
Reading eye charts. Quick scans to map the eye's surface. Short questionnaires about vision quality (e.g., glare at night or reading small print).
Why does this matter?
If successful, FSAK could:
- Help people see clearly longer after cataract surgery.
- Reduce the need for glasses or contacts.
- Give doctors better tools to personalize treatment.
Who's involved?
Led by eye specialists at Fudan University Eye \& ENT Hospital and Shanghai Peace Eye Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FSAK with Cataract Surgery | – | Procedure: femtosecond laser-assisted arcuate keratotomy (FSAK) combined with standard cataract surgeryParticipants in this group undergo femtosecond laser-assisted arcuate keratotomy (FSAK) combined with standard cataract surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with regular corneal astigmatism of 0.75-2.0 D who plan to undergo cataract surgery. Aged between 20 and 80 years old.
Key inclusion criteria (7 listed)
- Age: 20-80 years
- Age-related cataracts
- Regular corneal astigmatism (0.75-2.0 diopters) confirmed by Pentacam/IOLMaster 700
- Surgical Plan: Scheduled for femtosecond laser-assisted cataract surgery
- Central corneal thickness ≥500 µm
Key exclusion criteria (13 listed)
- Prior corneal refractive surgery (e.g., LASIK, PRK)
- Intraocular surgery (e.g., glaucoma filtering surgery)
- Irregular astigmatism (keratoconus, scarring, post-traumatic distortion)
- Active ocular inflammation or infection
- Corneal endothelial disease (e.g., Fuchs' dystrophy)
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 |
|---|---|---|
| femtosecond laser-assisted arcuate keratotomy (FSAK) combined with standard cataract surgery1. 5-year follow-up assessing stability of astigmatism correction. Most FSAK studies track ≤2 years. This addresses critical evidence gaps in durability 2. Combines topographic data with patient-reported visual function (VF-14/QoV questionnaires at all visits. Links anatomical changes to real-world visual experiences | Procedure or surgery | FSAK with Cataract Surgery |
Primary outcome
Change in corneal astigmatism magnitude (diopters) from baseline
Time frame: Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively
6 secondary outcomes
Visual Acuity-UCVA
Time frame: Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively
Visual acuity-BCVA
Time frame: Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively
Manifest refraction spherical equivalent (MRSE) in Diopter (D)
Time frame: Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively
Corneal Topography
Time frame: Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively
Objective Optical Quality
Time frame: Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively
Patient-Reported Outcomes
Time frame: Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively
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 23 Jul 2025.
- Individual participant dataSharing planned: No. Data contain sensitive biometric identifiers (e.g., corneal topography maps) that cannot be fully de-identified
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Astigmatism and Cataract, run by Eye & ENT Hospital of Fudan University at 1 site in China.
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 7 inclusion and 13 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 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
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 Jin Yang, PhD (13671632525, jin_er76@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in corneal astigmatism magnitude (diopters) from baseline (time frame: Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively). 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 23 Jul 2025.