Cataract SurgeryPRECISENCT07856849
The Effect of Capsulotomy Size on Effective Lens Position in Robotic Laser Cataract Surgery
A study testing Femtosecond Laser Capsulotomy - Small Size (4.6 mm) and Femtosecond Laser Capsulotomy - Large Size (5.6 mm) in people with Cataract Surgery and Intraocular Lens Position, run by Twin Cities Eye Consultants at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether the size of the opening made during laser-assisted cataract surgery affects where the artificial lens sits in the eye and the glasses prescription after surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract Surgery, Intraocular Lens Position, Refractive Outcomes After Cataract Surgery
- What is being tested?
- Femtosecond Laser Capsulotomy - Small Size (4.6 mm) and Femtosecond Laser Capsulotomy - Large Size (5.6 mm)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2025to 6 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 years or older
- General ocular health sufficient to allow accurate biometry and visual outcome measurements
- Candidates for femtosecond laser-assisted cataract surgery using the LENSAR ALLY® system
- Best-corrected visual acuity (BCVA) of 20/70 or better in both eyes
- Visual impairment primarily attributable to cataract
- Dilated pupil size of at least 7.5 mm in both eyes
Show all 11Show fewer
- Scheduled for bilateral cataract surgery with standard postoperative care
- Eligible for implantation of a monofocal ZCB00 intraocular lens (Johnson \& Johnson Vision) in both eyes
- Ability to read and understand the informed consent form in English
- Willingness and ability to comply with all study procedures and follow-up visits, including the 12-week postoperative visit
- Ability to provide written informed consent
Who cannot join
- Anatomically narrow angles at high risk of occlusion from pharmacologic dilation
- Clinically significant ocular pathology other than cataract that may compromise study outcomes
- History of clinically significant ocular inflammation or infection within 6 months prior to screening
- History of corneal transplant or clinically significant corneal dystrophy, including Fuchs' dystrophy with 12 or more confluent guttae
- History of prior corneal refractive surgery, including RK, LASIK, or PRK
- Complicated cataracts, including mature, hypermature, or traumatic cataracts
Show all 12Show fewer
- Uncontrolled systemic disease that may place the participant at risk or prevent study completion
- Inability to follow instructions or physically comply with imaging or positioning requirements
- Intraoperative complications such as posterior capsule rupture, vitreous loss, or zonular dehiscence
- Known allergy or sensitivity to perioperative medications or study-related materials
- Inability to provide informed consent or comply with study procedures
- Participation in another drug or device clinical trial within 30 days prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Twin Cities Eye Consultants, Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota, 55433
About this study
Official title: PRECISE - The Effect of Capsulotomy Size on Effective Lens Position in Robotic Laser Cataract Surgery
The goal of this clinical trial is to learn whether the size of the opening made during laser-assisted cataract surgery affects where the artificial lens sits in the eye and the glasses prescription after surgery.
This study includes adults aged 40 years and older who are scheduled to have cataract surgery in both eyes. Cataract surgery removes the cloudy natural lens of the eye and replaces it with a clear artificial lens, called an intraocular lens.
Read more
The main questions this study aims to answer are:
- Does the size of the capsulotomy (the circular opening made during surgery) affect the final position of the lens implant?
- Does capsulotomy size affect vision or glasses prescription after surgery?
Each participant will receive two different capsulotomy sizes, one in each eye. The size (big or small) used in each eye is chosen by chance. Both sizes are safe and commonly used during cataract surgery. All surgeries use a laser system that allows the opening to be made very precisely.
Participants will:
- Attend one study visit before surgery for eye exams and imaging
- Undergo standard cataract surgery in both eyes using laser assistance
- Attend one final study visit about 12 weeks after the second surgery for repeat eye exams and imaging
Participants will receive the same type of lens implant and standard follow-up care whether or not they join the study. There is no direct benefit from taking part. The information learned may help doctors improve planning and accuracy for future cataract surgeries.
Read the detailed description
Accurate prediction of effective lens position (ELP) is a critical factor in achieving optimal refractive outcomes following cataract surgery. Even small variations in the postoperative position of an intraocular lens (IOL) can influence refractive accuracy and patient satisfaction. One surgical factor that may contribute to ELP variability is the size of the anterior capsulotomy, which affects IOL centration, capsular overlap, and long-term stability within the capsular bag.
The PRECISE study is a prospective, randomized, within-subject clinical investigation designed to evaluate the effect of capsulotomy size on postoperative effective lens position and refractive outcomes in patients undergoing femtosecond laser-assisted cataract surgery. By using a paired-eye design, each participant serves as their own control, thereby minimizing inter-individual variability related to ocular anatomy, wound healing, and biometric differences.
All surgical procedures are performed using the LENSAR ALLY® femtosecond laser system, which allows for highly precise, reproducible, and well-centered capsulotomies. Two different capsulotomy sizes are used in this study, 4.6 mm and 5.6 mm, both of which fall within accepted standards of care and are commonly employed in routine cataract surgery. Capsulotomy size assignment is randomized between eyes. Aside from capsulotomy size, all other aspects of the surgical procedure, including IOL model and surgical technique, remain consistent with standard clinical practice.
Participants undergo comprehensive preoperative evaluation, including visual acuity testing, ocular biometry, optical coherence tomography imaging, and slit-lamp examination. These assessments are repeated at a final postoperative study visit approximately 12 weeks after the second eye surgery to evaluate lens position and refractive status. Standard postoperative follow-up visits required for routine cataract care are conducted separately and are not altered by study participation.
The study focuses on detecting subtle differences in effective lens position and refractive outcomes that may be associated with capsulotomy size. Any anticipated differences in ELP are expected to be small and unlikely to result in clinically noticeable visual changes for participants. However, identifying consistent trends may provide insight into the role of capsulotomy geometry in IOL behavior and help refine IOL power calculations, surgical planning, and refractive predictability in future cataract surgery patients.
No experimental devices or medications are used in this study. All participants receive standard monofocal intraocular lenses and routine perioperative care. The risks associated with participation are consistent with those of standard cataract surgery, and no additional study-specific risks are anticipated.
Overall, this study aims to contribute to a better understanding of the relationship between femtosecond laser capsulotomy size and postoperative lens position, with the long-term goal of improving precision and outcomes in cataract surgery.
- Conditions
- Cataract Surgery, Intraocular Lens Position, Refractive Outcomes After Cataract Surgery, Cataract
- Being tested
- Femtosecond Laser Capsulotomy - Small Size (4.6 mm), Femtosecond Laser Capsulotomy - Large Size (5.6 mm)
- Keywords
- Cataract Surgery, Femtosecond Laser-Assisted Cataract Surgery, Capsulotomy Size, Effective Lens Position, Intraocular Lens Implantation, Refractive Outcomes, Laser Capsulotomy, Monofocal Intraocular Lens, LENSAR ALLY Laser
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond Laser Capsulotomy - Small Size (4.6 mm)Procedure or surgery
Also called LENSAR ALLY Laser Capsulotomy (Small), 4.6 mm
Femtosecond laser-assisted cataract surgery in which a smaller capsulotomy (4.6 mm) is created using the LENSAR ALLY laser system. The capsulotomy size is within standard clinical practice and is randomly assigned to one eye. All other aspects of cataract surgery, including intraocular lens implantation and postoperative care, follow routine clinical standards.
Femtosecond Laser Capsulotomy - Large Size (5.6 mm)Procedure or surgery
Also called LENSAR ALLY Laser Capsulotomy (Large), 5.6 mm
Femtosecond laser-assisted cataract surgery in which a larger capsulotomy (5.6 mm) is created using the LENSAR ALLY laser system. The capsulotomy size is within standard clinical practice and is randomly assigned to the contralateral eye. All other aspects of cataract surgery, including intraocular lens implantation and postoperative care, follow routine clinical standards.
| Study group | Role | What they receive |
|---|---|---|
| Small Capsulotomy Size (4.6 mm) | Experimental | Participants will receive femtosecond laser-assisted cataract surgery with a smaller capsulotomy size (4.6 mm) created using the LENSAR ALLY laser system. This capsulotomy size is within standard clinical practice and is randomly assigned to one eye. Receives: Procedure: Femtosecond Laser Capsulotomy - Small Size (4.6 mm) |
| Large Capsulotomy Size (5.6 mm) | Experimental | Participants will receive femtosecond laser-assisted cataract surgery with a larger capsulotomy size (5.6 mm) created using the LENSAR ALLY laser system. This capsulotomy size is within standard clinical practice and is randomly assigned to the contralateral eye. Receives: Procedure: Femtosecond Laser Capsulotomy - Large Size (5.6 mm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Chamber Depth (ACD)
Difference in anterior chamber depth (ACD) between eyes receiving a 4.6 mm femtosecond laser capsulotomy and eyes receiving a 5.6 mm femtosecond laser capsulotomy. ACD will be measured using standard optical biometry to assess the final position of the implanted monofocal intraocular lens.
Measured: 12 weeks after second eye surgery
Secondary outcomes (3)
Refractive Accuracy (MRSE vs Target Refraction)
Difference between the manifest refraction spherical equivalent (MRSE) and the intended target refraction for each eye following cataract surgery, comparing eyes with different capsulotomy sizes.
Measured: 12 weeks after second eye surgery
Residual Refractive Error Distribution
Percentage of eyes within ±0.25 D, ±0.50 D, ±0.75 D, and ±1.00 D of target refraction following cataract surgery, comparing eyes receiving a 4.6 mm versus a 5.6 mm capsulotomy.
Measured: 12 weeks after second eye surgery
Distance Visual Acuity Outcomes
Uncorrected distance visual acuity (UDVA) and best-corrected distance visual acuity (BCVA) following cataract surgery, reported as the percentage of eyes achieving visual acuity thresholds of 20/20, 20/25, 20/32, 20/40, and 20/60 or worse, comparing eyes with different capsulotomy sizes.
Measured: 12 weeks after second eye surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start27 Oct 2025
- Primary completion6 Mar 2026
- Study completion6 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cataract SurgeryStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, within-subject (paired-eye) study design. Each participant undergoes cataract surgery in both eyes, with each eye randomly assigned a different capsulotomy size. Because each participant receives both interventions, each participant serves as their own control, reducing variability related to individual anatomy and healing differences.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Twin Cities Eye Consultants
- Sponsor type
- University, hospital or other
- Collaborators
- LensAR Incorporated
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856849
- Sponsor's protocol ID
- TCEC-005
- Acronym
- PRECISE
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JH, Lee YE, Joo CK. Clinical results of the open ring PMMA guider assisted capsulorrhexis in cataract surgery. BMC Ophthalmol. 2018 May 10;18(1):116. doi: 10.1186/s12886-018-0782-6.
PubMed 29747619Sharma B, Abell RG, Arora T, Antony T, Vajpayee RB. Techniques of anterior capsulotomy in cataract surgery. Indian J Ophthalmol. 2019 Apr;67(4):450-460. doi: 10.4103/ijo.IJO_1728_18.
PubMed 30900573Zhu Y, Shi K, Yao K, Wang Y, Zheng S, Xu W, Chen P, Yu Y, Shentu X. Parameters of Capsulorrhexis and Intraocular Lens Decentration After Femtosecond and Manual Capsulotomies in High Myopic Patients With Cataracts. Front Med (Lausanne). 2021 Mar 11;8:640269. doi: 10.3389/fmed.2021.640269. eCollection 2021.
PubMed 33777981Packer M, Teuma EV, Glasser A, Bott S. Defining the ideal femtosecond laser capsulotomy. Br J Ophthalmol. 2015 Aug;99(8):1137-42. doi: 10.1136/bjophthalmol-2014-306065. Epub 2015 Mar 31.
PubMed 25829488Li S, Hu Y, Guo R, Shao Y, Zhao J, Zhang J, Wang J. The effects of different shapes of capsulorrhexis on postoperative refractive outcomes and the effective position of the intraocular lens in cataract surgery. BMC Ophthalmol. 2019 Feb 21;19(1):59. doi: 10.1186/s12886-019-1068-3.
PubMed 30791880
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRECISE - The Effect of Capsulotomy Size on Effective Lens Position in Robotic Laser Cataract Surgery
- ClinicalTrials.gov ID
- NCT07856849
- Acronym / sponsor ID
- PRECISE / TCEC-005
- Conditions
- Cataract Surgery, Intraocular Lens Position, Refractive Outcomes After Cataract Surgery, Cataract
- Keywords
- Cataract Surgery, Femtosecond Laser-Assisted Cataract Surgery, Capsulotomy Size, Effective Lens Position, Intraocular Lens Implantation, Refractive Outcomes, Laser Capsulotomy, Monofocal Intraocular Lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Twin Cities Eye ConsultantsUniversity, hospital or other
- Collaborators
- LensAR Incorporated
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 6 Mar 2026 (actual)
- Study completion
- 6 Mar 2026 (actual)
- First posted
- 5 Oct 2026 (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.
The goal of this clinical trial is to learn whether the size of the opening made during laser-assisted cataract surgery affects where the artificial lens sits in the eye and the glasses prescription after surgery.
This study includes adults aged 40 years and older who are scheduled to have cataract surgery in both eyes. Cataract surgery removes the cloudy natural lens of the eye and replaces it with a clear artificial lens, called an intraocular lens.
The main questions this study aims to answer are:
- Does the size of the capsulotomy (the circular opening made during surgery) affect the final position of the lens implant?
- Does capsulotomy size affect vision or glasses prescription after surgery?
Each participant will receive two different capsulotomy sizes, one in each eye. The size (big or small) used in each eye is chosen by chance. Both sizes are safe and commonly used during cataract surgery. All surgeries use a laser system that allows the opening to be made very precisely.
Participants will:
- Attend one study visit before surgery for eye exams and imaging
- Undergo standard cataract surgery in both eyes using laser assistance
- Attend one final study visit about 12 weeks after the second surgery for repeat eye exams and imaging
Participants will receive the same type of lens implant and standard follow-up care whether or not they join the study. There is no direct benefit from taking part. The information learned may help doctors improve planning and accuracy for future cataract surgeries.
Detailed description
Accurate prediction of effective lens position (ELP) is a critical factor in achieving optimal refractive outcomes following cataract surgery. Even small variations in the postoperative position of an intraocular lens (IOL) can influence refractive accuracy and patient satisfaction. One surgical factor that may contribute to ELP variability is the size of the anterior capsulotomy, which affects IOL centration, capsular overlap, and long-term stability within the capsular bag.
The PRECISE study is a prospective, randomized, within-subject clinical investigation designed to evaluate the effect of capsulotomy size on postoperative effective lens position and refractive outcomes in patients undergoing femtosecond laser-assisted cataract surgery. By using a paired-eye design, each participant serves as their own control, thereby minimizing inter-individual variability related to ocular anatomy, wound healing, and biometric differences.
All surgical procedures are performed using the LENSAR ALLY® femtosecond laser system, which allows for highly precise, reproducible, and well-centered capsulotomies. Two different capsulotomy sizes are used in this study, 4.6 mm and 5.6 mm, both of which fall within accepted standards of care and are commonly employed in routine cataract surgery. Capsulotomy size assignment is randomized between eyes. Aside from capsulotomy size, all other aspects of the surgical procedure, including IOL model and surgical technique, remain consistent with standard clinical practice.
Participants undergo comprehensive preoperative evaluation, including visual acuity testing, ocular biometry, optical coherence tomography imaging, and slit-lamp examination. These assessments are repeated at a final postoperative study visit approximately 12 weeks after the second eye surgery to evaluate lens position and refractive status. Standard postoperative follow-up visits required for routine cataract care are conducted separately and are not altered by study participation.
The study focuses on detecting subtle differences in effective lens position and refractive outcomes that may be associated with capsulotomy size. Any anticipated differences in ELP are expected to be small and unlikely to result in clinically noticeable visual changes for participants. However, identifying consistent trends may provide insight into the role of capsulotomy geometry in IOL behavior and help refine IOL power calculations, surgical planning, and refractive predictability in future cataract surgery patients.
No experimental devices or medications are used in this study. All participants receive standard monofocal intraocular lenses and routine perioperative care. The risks associated with participation are consistent with those of standard cataract surgery, and no additional study-specific risks are anticipated.
Overall, this study aims to contribute to a better understanding of the relationship between femtosecond laser capsulotomy size and postoperative lens position, with the long-term goal of improving precision and outcomes in cataract surgery.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, within-subject (paired-eye) study design. Each participant undergoes cataract surgery in both eyes, with each eye randomly assigned a different capsulotomy size. Because each participant receives both interventions, each participant serves as their own control, reducing variability related to individual anatomy and healing differences.
| Arm | Type | Receives |
|---|---|---|
| Small Capsulotomy Size (4.6 mm) | Experimental | Procedure: Femtosecond Laser Capsulotomy - Small Size (4.6 mm)Participants will receive femtosecond laser-assisted cataract surgery with a smaller capsulotomy size (4.6 mm) created using the LENSAR ALLY laser system. This capsulotomy size is within standard clinical practice and is randomly assigned to one eye. |
| Large Capsulotomy Size (5.6 mm) | Experimental | Procedure: Femtosecond Laser Capsulotomy - Large Size (5.6 mm)Participants will receive femtosecond laser-assisted cataract surgery with a larger capsulotomy size (5.6 mm) created using the LENSAR ALLY laser system. This capsulotomy size is within standard clinical practice and is randomly assigned to the contralateral eye. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 40 years or older
- General ocular health sufficient to allow accurate biometry and visual outcome measurements
- Candidates for femtosecond laser-assisted cataract surgery using the LENSAR ALLY® system
- Best-corrected visual acuity (BCVA) of 20/70 or better in both eyes
- Visual impairment primarily attributable to cataract
Key exclusion criteria (12 listed)
- Anatomically narrow angles at high risk of occlusion from pharmacologic dilation
- Clinically significant ocular pathology other than cataract that may compromise study outcomes
- History of clinically significant ocular inflammation or infection within 6 months prior to screening
- History of corneal transplant or clinically significant corneal dystrophy, including Fuchs' dystrophy with 12 or more confluent guttae
- History of prior corneal refractive surgery, including RK, LASIK, or PRK
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 Capsulotomy - Small Size (4.6 mm)Also: LENSAR ALLY Laser Capsulotomy (Small), 4.6 mmFemtosecond laser-assisted cataract surgery in which a smaller capsulotomy (4.6 mm) is created using the LENSAR ALLY laser system. The capsulotomy size is within standard clinical practice and is randomly assigned to one eye. All other aspects of cataract surgery, including intraocular lens implantation and postoperative care, follow routine clinical standards. | Procedure or surgery | Small Capsulotomy Size (4.6 mm) |
| Femtosecond Laser Capsulotomy - Large Size (5.6 mm)Also: LENSAR ALLY Laser Capsulotomy (Large), 5.6 mmFemtosecond laser-assisted cataract surgery in which a larger capsulotomy (5.6 mm) is created using the LENSAR ALLY laser system. The capsulotomy size is within standard clinical practice and is randomly assigned to the contralateral eye. All other aspects of cataract surgery, including intraocular lens implantation and postoperative care, follow routine clinical standards. | Procedure or surgery | Large Capsulotomy Size (5.6 mm) |
Primary outcome
Anterior Chamber Depth (ACD)
Time frame: 12 weeks after second eye surgery
Difference in anterior chamber depth (ACD) between eyes receiving a 4.6 mm femtosecond laser capsulotomy and eyes receiving a 5.6 mm femtosecond laser capsulotomy. ACD will be measured using standard optical biometry to assess the final position of the implanted monofocal intraocular lens.
3 secondary outcomes
Refractive Accuracy (MRSE vs Target Refraction)
Time frame: 12 weeks after second eye surgery
Residual Refractive Error Distribution
Time frame: 12 weeks after second eye surgery
Distance Visual Acuity Outcomes
Time frame: 12 weeks after second eye surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: PubMed 29747619Lee JH, Lee YE, Joo CK. Clinical results of the open ring PMMA guider assisted capsulorrhexis in cataract surgery. BMC Ophthalmol. 2018 May 10;18(1):116. doi: 10.1186/s12886-018-0782-6.
- Background: PubMed 30900573Sharma B, Abell RG, Arora T, Antony T, Vajpayee RB. Techniques of anterior capsulotomy in cataract surgery. Indian J Ophthalmol. 2019 Apr;67(4):450-460. doi: 10.4103/ijo.IJO_1728_18.
- Background: PubMed 33777981Zhu Y, Shi K, Yao K, Wang Y, Zheng S, Xu W, Chen P, Yu Y, Shentu X. Parameters of Capsulorrhexis and Intraocular Lens Decentration After Femtosecond and Manual Capsulotomies in High Myopic Patients With Cataracts. Front Med (Lausanne). 2021 Mar 11;8:640269. doi: 10.3389/fmed.2021.640269. eCollection 2021.
- Background: PubMed 25829488Packer M, Teuma EV, Glasser A, Bott S. Defining the ideal femtosecond laser capsulotomy. Br J Ophthalmol. 2015 Aug;99(8):1137-42. doi: 10.1136/bjophthalmol-2014-306065. Epub 2015 Mar 31.
- Background: PubMed 30791880Li S, Hu Y, Guo R, Shao Y, Zhao J, Zhang J, Wang J. The effects of different shapes of capsulorrhexis on postoperative refractive outcomes and the effective position of the intraocular lens in cataract surgery. BMC Ophthalmol. 2019 Feb 21;19(1):59. doi: 10.1186/s12886-019-1068-3.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femtosecond Laser Capsulotomy - Small Size (4.6 mm) and Femtosecond Laser Capsulotomy - Large Size (5.6 mm) in people with Cataract Surgery and Intraocular Lens Position, run by Twin Cities Eye Consultants at 1 site 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 11 inclusion and 12 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: finished, as of the sponsor's last update on 5 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 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior Chamber Depth (ACD) (time frame: 12 weeks after second eye surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07856849, which also lists 5 linked publications.
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 5 Oct 2026.