Nuclear Sclerosis of the LensNCT01878838
The Comparison of Cataract Lasers Using the Optimedica Catalys Laser and the Alcon LenSx Laser.
A study testing Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser and Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser in people with Nuclear Sclerosis of the Lens and Posterior Subcapsular Cataract, run by Steven H. Linn, OD at 1 site in United States.
Trial summary
This study compares two FDA approved Cataract Lasers. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Nuclear Sclerosis of the Lens, Posterior Subcapsular Cataract, Cortical Cataract
- What is being tested?
- Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser and Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jan 2014
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have grade 2 to 4 nuclear sclerotic and or cortical or posterior subcapsular cataracts with visual impairment.
- Pupillary dilation of at least 6.0 mm
- Axial length between 21 mm to 26 mm
- Age ≥ 22 years of either gender
- Require laser assisted corneal incisions, capsulotomy and nucleus segmentation
- Understand and sign a written Informed Consent form
- Be able to comply with the treatment and follow-up schedule
Who cannot join
- Enrolment in another drug or device study within the prior 3 months
- History of ocular trauma
- Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.)
- Uncontrolled systemic or ocular disease
- Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies, severe corneal opacities, significant corneal edema, etc)
- Diminished aqueous clarity that obscures OCT imaging of the anterior lens capsule
Show all 11Show fewer
- Corneal ring and/or inlay implant(s)
- Pseudoexfoliation
- Known steroid IOP responder or ocular hypertension IOP >25 mmHg by tonometry
- Retinal detachment within the last 6 months
- Anterior chamber depth less than 2.5 mm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Clinical Trial Comparing the Intra-operative Effects, Safety, Efficacy and Performance of Two Commercially Available Laser Systems in Patients Undergoing Femtosecond Laser-Assisted Cataract Surgery.
This study compares two FDA approved Cataract Lasers.
Read the detailed description
The purpose of this study is to systematically evaluate the performance of two commercially available and FDA cleared femtosecond laser systems in patients undergoing femtosecond laser-assisted cataract surgery. Objective data on the repeatability and accuracy of the studied parameters will be gathered and reported as endpoints of the study.
The two systems studied are the Catalys™ Precision Laser System (OptiMedica, CA, USA) and the LenSx® Laser System (Alcon Laboratories, Inc., Fort Worth, TX).
Published data have suggested that the femtosecond laser is a useful tool for cataract surgery.
This study is to determine whether differences or similarities exist in specific treatment parameters achieved with two FDA cleared and commercially available femtosecond laser cataract surgery platforms
- Being tested
- Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser, Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser
- Medical subject headings
- Cataract, Age-Related Nuclear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond Laser Assisted Cataract Surgery w/ Catalys LaserProcedure or surgery
Also called Optimedica Catalys Precision Laser System
Cohort subjects will undergo Femtosecond Laser Assisted Cataract Surgery in both eyes, with the Optimedica Catalys laser on one eye, and the Alcon LensX laser on the other. First eyes will be randomized.
Femtosecond Laser Assisted Cataract Surgery w/ LenSx LaserProcedure or surgery
Also called Alcon LenSx Laser System
Cohort subjects will undergo Femtosecond Laser Assisted Cataract Surgery in both eyes, with the Optimedica Catalys laser on one eye, and the Alcon LensX laser on the other. First eyes will be randomized.
| Study group | Role | What they receive |
|---|---|---|
| Catalys Treated Eyes | Active comparator | Patient's aged 22 and older with visually significant cataracts undergoing Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser Receives: Procedure: Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser |
| LenSx Treated Eyes | Active comparator | Patient's aged 22 and older with visually significant cataracts undergoing Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser. Receives: Procedure: Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Dissipated Energy
The total amount of phacoemulsification energy delivered during the procedure.
Measured: Intraoperative
Secondary outcomes (1)
Complete Laser Capsulotomy
Did the laser perform a complete capsulotomy with no tags or untreated segments.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Nuclear Sclerosis of the LensStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven H. Linn, OD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steven H. Linn, OD, Hoopes Vision
- Investigators
- Robert P Rivera, MD, Principal investigator, Hoopes VisionSteven H Linn, OD, Study director, Hoopes Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878838
- Sponsor's protocol ID
- HV-AVO1
- Status last verified
- Mar 2025
- First submitted
- 12 Jun 2013
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report. 2009 Jan 28;(11):1-25.
PubMed 19294964Vasavada AR, Vasavada V, Vasavada VA, Praveen MR, Johar SR, Gajjar D, Arora AI. Comparison of the effect of torsional and microburst longitudinal ultrasound on clear corneal incisions during phacoemulsification. J Cataract Refract Surg. 2012 May;38(5):833-9. doi: 10.1016/j.jcrs.2011.11.050.
PubMed 22520307Georgescu D, Kuo AF, Kinard KI, Olson RJ. A fluidics comparison of Alcon Infiniti, Bausch & Lomb Stellaris, and Advanced Medical Optics Signature phacoemulsification machines. Am J Ophthalmol. 2008 Jun;145(6):1014-1017. doi: 10.1016/j.ajo.2008.01.024. Epub 2008 Mar 17.
PubMed 18343350Dooley IJ, O'Brien PD. Subjective difficulty of each stage of phacoemulsification cataract surgery performed by basic surgical trainees. J Cataract Refract Surg. 2006 Apr;32(4):604-8. doi: 10.1016/j.jcrs.2006.01.045.
PubMed 16698480Gimbel HV, Neuhann T. Development, advantages, and methods of the continuous circular capsulorhexis technique. J Cataract Refract Surg. 1990 Jan;16(1):31-7. doi: 10.1016/s0886-3350(13)80870-x.
PubMed 2299571Friedman NJ, Palanker DV, Schuele G, Andersen D, Marcellino G, Seibel BS, Batlle J, Feliz R, Talamo JH, Blumenkranz MS, Culbertson WW. Femtosecond laser capsulotomy. J Cataract Refract Surg. 2011 Jul;37(7):1189-98. doi: 10.1016/j.jcrs.2011.04.022.
PubMed 21700099Artzen D, Lundstrom M, Behndig A, Stenevi U, Lydahl E, Montan P. Capsule complication during cataract surgery: Case-control study of preoperative and intraoperative risk factors: Swedish Capsule Rupture Study Group report 2. J Cataract Refract Surg. 2009 Oct;35(10):1688-93. doi: 10.1016/j.jcrs.2009.05.026.
PubMed 19781460Bellini LP, Brum GS, Grossi RS, Borowsky C. Cataract surgery complication rates. Ophthalmology. 2008 Aug;115(8):1432; author reply 1432-3. doi: 10.1016/j.ophtha.2008.04.009. No abstract available.
PubMed 18675698Richard J, Hoffart L, Chavane F, Ridings B, Conrath J. Corneal endothelial cell loss after cataract extraction by using ultrasound phacoemulsification versus a fluid-based system. Cornea. 2008 Jan;27(1):17-21. doi: 10.1097/ICO.0b013e3181583115.
PubMed 18245961Hayashi K, Hayashi H, Nakao F, Hayashi F. Risk factors for corneal endothelial injury during phacoemulsification. J Cataract Refract Surg. 1996 Oct;22(8):1079-84. doi: 10.1016/s0886-3350(96)80121-0.
PubMed 8915805Uy HS, Edwards K, Curtis N. Femtosecond phacoemulsification: the business and the medicine. Curr Opin Ophthalmol. 2012 Jan;23(1):33-9. doi: 10.1097/ICU.0b013e32834cd622.
PubMed 22081031
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Clinical Trial Comparing the Intra-operative Effects, Safety, Efficacy and Performance of Two Commercially Available Laser Systems in Patients Undergoing Femtosecond Laser-Assisted Cataract Surgery.
- ClinicalTrials.gov ID
- NCT01878838
- Acronym / sponsor ID
- HV-AVO1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Steven H. Linn, ODUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Jun 2013 (estimated)
- 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 compares two FDA approved Cataract Lasers.
Detailed description
The purpose of this study is to systematically evaluate the performance of two commercially available and FDA cleared femtosecond laser systems in patients undergoing femtosecond laser-assisted cataract surgery. Objective data on the repeatability and accuracy of the studied parameters will be gathered and reported as endpoints of the study.
The two systems studied are the Catalys™ Precision Laser System (OptiMedica, CA, USA) and the LenSx® Laser System (Alcon Laboratories, Inc., Fort Worth, TX).
Published data have suggested that the femtosecond laser is a useful tool for cataract surgery.
This study is to determine whether differences or similarities exist in specific treatment parameters achieved with two FDA cleared and commercially available femtosecond laser cataract surgery platforms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catalys Treated Eyes | Active comparator | Procedure: Femtosecond Laser Assisted Cataract Surgery w/ Catalys LaserPatient's aged 22 and older with visually significant cataracts undergoing Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser |
| LenSx Treated Eyes | Active comparator | Procedure: Femtosecond Laser Assisted Cataract Surgery w/ LenSx LaserPatient's aged 22 and older with visually significant cataracts undergoing Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have grade 2 to 4 nuclear sclerotic and or cortical or posterior subcapsular cataracts with visual impairment.
- Pupillary dilation of at least 6.0 mm
- Axial length between 21 mm to 26 mm
- Age ≥ 22 years of either gender
- Require laser assisted corneal incisions, capsulotomy and nucleus segmentation
Key exclusion criteria (11 listed)
- Enrolment in another drug or device study within the prior 3 months
- History of ocular trauma
- Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.)
- Uncontrolled systemic or ocular disease
- Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies, severe corneal opacities, significant corneal edema, etc)
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 Cataract Surgery w/ Catalys LaserAlso: Optimedica Catalys Precision Laser SystemCohort subjects will undergo Femtosecond Laser Assisted Cataract Surgery in both eyes, with the Optimedica Catalys laser on one eye, and the Alcon LensX laser on the other. First eyes will be randomized. | Procedure or surgery | Catalys Treated Eyes |
| Femtosecond Laser Assisted Cataract Surgery w/ LenSx LaserAlso: Alcon LenSx Laser SystemCohort subjects will undergo Femtosecond Laser Assisted Cataract Surgery in both eyes, with the Optimedica Catalys laser on one eye, and the Alcon LensX laser on the other. First eyes will be randomized. | Procedure or surgery | LenSx Treated Eyes |
Primary outcome
Cumulative Dissipated Energy
Time frame: Intraoperative
The total amount of phacoemulsification energy delivered during the procedure.
1 secondary outcome
Complete Laser Capsulotomy
Time frame: Intraoperative
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 11 Mar 2025.
- Background: PubMed 19294964Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report. 2009 Jan 28;(11):1-25.
- Background: PubMed 22520307Vasavada AR, Vasavada V, Vasavada VA, Praveen MR, Johar SR, Gajjar D, Arora AI. Comparison of the effect of torsional and microburst longitudinal ultrasound on clear corneal incisions during phacoemulsification. J Cataract Refract Surg. 2012 May;38(5):833-9. doi: 10.1016/j.jcrs.2011.11.050.
- Background: PubMed 18343350Georgescu D, Kuo AF, Kinard KI, Olson RJ. A fluidics comparison of Alcon Infiniti, Bausch & Lomb Stellaris, and Advanced Medical Optics Signature phacoemulsification machines. Am J Ophthalmol. 2008 Jun;145(6):1014-1017. doi: 10.1016/j.ajo.2008.01.024. Epub 2008 Mar 17.
- Background: PubMed 16698480Dooley IJ, O'Brien PD. Subjective difficulty of each stage of phacoemulsification cataract surgery performed by basic surgical trainees. J Cataract Refract Surg. 2006 Apr;32(4):604-8. doi: 10.1016/j.jcrs.2006.01.045.
- Background: PubMed 2299571Gimbel HV, Neuhann T. Development, advantages, and methods of the continuous circular capsulorhexis technique. J Cataract Refract Surg. 1990 Jan;16(1):31-7. doi: 10.1016/s0886-3350(13)80870-x.
- Background: PubMed 21700099Friedman NJ, Palanker DV, Schuele G, Andersen D, Marcellino G, Seibel BS, Batlle J, Feliz R, Talamo JH, Blumenkranz MS, Culbertson WW. Femtosecond laser capsulotomy. J Cataract Refract Surg. 2011 Jul;37(7):1189-98. doi: 10.1016/j.jcrs.2011.04.022.
- Background: PubMed 19781460Artzen D, Lundstrom M, Behndig A, Stenevi U, Lydahl E, Montan P. Capsule complication during cataract surgery: Case-control study of preoperative and intraoperative risk factors: Swedish Capsule Rupture Study Group report 2. J Cataract Refract Surg. 2009 Oct;35(10):1688-93. doi: 10.1016/j.jcrs.2009.05.026.
- Background: PubMed 18675698Bellini LP, Brum GS, Grossi RS, Borowsky C. Cataract surgery complication rates. Ophthalmology. 2008 Aug;115(8):1432; author reply 1432-3. doi: 10.1016/j.ophtha.2008.04.009. No abstract available.
- Background: PubMed 18245961Richard J, Hoffart L, Chavane F, Ridings B, Conrath J. Corneal endothelial cell loss after cataract extraction by using ultrasound phacoemulsification versus a fluid-based system. Cornea. 2008 Jan;27(1):17-21. doi: 10.1097/ICO.0b013e3181583115.
- Background: PubMed 8915805Hayashi K, Hayashi H, Nakao F, Hayashi F. Risk factors for corneal endothelial injury during phacoemulsification. J Cataract Refract Surg. 1996 Oct;22(8):1079-84. doi: 10.1016/s0886-3350(96)80121-0.
- Background: PubMed 22081031Uy HS, Edwards K, Curtis N. Femtosecond phacoemulsification: the business and the medicine. Curr Opin Ophthalmol. 2012 Jan;23(1):33-9. doi: 10.1097/ICU.0b013e32834cd622.
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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.
Robert P Rivera, MD principal investigator
Hoopes Vision
Steven H Linn, OD study director
Hoopes Vision
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 Assisted Cataract Surgery w/ Catalys Laser and Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser in people with Nuclear Sclerosis of the Lens and Posterior Subcapsular Cataract, run by Steven H. Linn, OD 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 7 inclusion and 11 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 11 Mar 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 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?
Cumulative Dissipated Energy (time frame: Intraoperative). 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 NCT01878838, which also lists 11 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 11 Mar 2025.