Biometer Testing for Cataracts
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called the Unity DX to collect detailed eye measurements. Researchers focus on individuals who need or have had certain types of eye implants, such as those for cataract surgery or vision correction after LASIK. The trial also includes individuals with keratoconus, a condition where the cornea thins and bulges. Ideal candidates are those planning eye surgery or who have had eye surgery before and can attend study visits. As a Phase 2 trial, this research measures how well the Unity DX works in an initial, smaller group, offering participants a chance to contribute to advancements in eye care technology.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that the Unity DX biometer is safe for collecting biometry and aberration data?
Research has shown that Alcon's monofocal and monofocal toric lenses for the eye are generally safe. Studies have found that these lenses perform well, and most people tolerate them without issues. For example, one study noted that these lenses improved vision and remained stable over time, with no major safety concerns.
Similarly, Alcon's multifocal lenses, which assist with age-related difficulty in seeing close objects, are also considered safe. Research indicates that people are generally satisfied with these lenses and rarely experience visual problems. The FDA has approved these lenses, further supporting their safety.
In summary, existing studies consider both the monofocal and multifocal lenses from Alcon safe. Many people have used them successfully without major problems.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to improve the precision of eye measurements for patients receiving Alcon intraocular lenses (IOLs). Unlike traditional methods, which often rely on less advanced imaging technologies, this study is evaluating advanced devices like the Unity DX and SMARTCataract DX Biometer, along with the IOLMaster 700 or Argos with Alcon Image Guidance. These state-of-the-art tools could lead to more accurate assessments, enhancing the outcomes for patients with various eye conditions, including those with keratoconus or previous refractive surgeries. The hope is to set a new standard of care that tailors lens implantation to individual needs, potentially offering better vision correction results.
What evidence suggests that the Unity DX biometer is effective for collecting biometry and aberration data?
This trial will evaluate different groups of subjects with various eye conditions and previous surgeries. Research has shown that Alcon monofocal and monofocal toric intraocular lenses (IOLs), studied in this trial, effectively improve vision after cataract surgery. These lenses replace the eye's natural lens, often enhancing distance vision without glasses and reducing astigmatism, a common cause of blurred vision. Studies have found that both Eyecryl toric and Alcon AcrySof IQ toric IOLs offer similar positive results.
For presbyopia, which involves difficulty seeing things up close, Alcon's multifocal IOLs are designed to improve vision at various distances. They provide good overall vision and clarity, making daily activities easier. However, some patients experience visual disturbances with certain models, although these lenses generally work well for many people.36789Who Is on the Research Team?
Principal II, Clinical Trial Operations, Vision Care
Principal Investigator
Alcon Research, LLC
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Data Collection
Biometry and aberrometry data are collected using Unity DX and other biometers
Follow-up
Participants are monitored for safety and effectiveness after data collection
What Are the Treatments Tested in This Trial?
Interventions
- Argos with Alcon Image Guidance Biometer
- IOLMaster 700 Biometer
- Unity DX and SMARTCataract DX (SCDX) Biometer
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Subjects/eyes with keratoconus, a progressive cornea disorder. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.
Subjects/eyes with with prior refractive surgery such as LASIK or PRK and planned implantation of an Alcon monofocal or monofocal toric IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.
Subjects/eyes with planned implantation of an Alcon monofocal or monofocal toric IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.
Subjects/eyes previously implanted with an Alcon monofocal or multifocal presbyopia correcting IOL. Measurements will be taken with Unity DX and SMARTCataract DX (SCDX) Biometer and either the IOLMaster 700 Biometer or the Argos with Alcon Image Guidance Biometer depending on which device is used at site.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alcon Research
Lead Sponsor
Raquel C. Bono
Alcon Research
Chief Medical Officer since 2022
MD from Harvard Medical School
David Endicott
Alcon Research
Chief Executive Officer since 2018
MBA from University of Southern California
Citations
AcrySof® IQ Monofocal and AcrySof® IQ Toric IOLs | Alcon ...
AcrySof® provides amongst the highest level of UV radiation filter. Some IOLs allow parts of UVA radiation to pass through the IOL and to the retina.1,12-15.
Building on Our Leadership in IOL Innovation
Cataracts are often corrected with the surgical implantation of an intraocular lens (IOL), which is an artificial replacement for the eye's lens. Expanding on ...
Comparison of clinical outcomes of Eyecryl toric and Alcon ...
Both Eyecryl toric and Alcon AcrySof IQ toric IOLs showed comparable post-operative outcomes in terms of UCVA and residual astigmatism.
Toric Monofocal Intraocular Lenses for the Correction of ...
Toric monofocal IOLs are effective in neutralizing pre-existing corneal astigmatism at the time of cataract surgery and result in better UCDVA ...
Cataract Surgery - Intraocular Lenses (IOLs)
Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. All ...
6.
myalcon.com
myalcon.com/international/professional/cataract-surgery/iols/clareon-monofocal-and-toric/Clareon® Monofocal IOL and Monofocal Toric IOL - MyAlcon
Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample. Clin Ophthalmol ...
Real-World Visual Outcomes and Rotational Stability of a ...
The Clareon aspheric monofocal toric IOL showed excellent improvement in distance visual acuity and treatment of astigmatism, with functional ...
8.
crstoday.com
crstoday.com/articles/expanding-the-clareon-iol-family/expanding-the-clareon-iol-familyExpanding the Clareon ® IOL Family
Effectiveness and safety of the Clareon monofocal intraocular lens: outcomes from a 12-month single-arm clinical study in a large sample.
Comprehensive Guide to Alcon AcrySof IQ Monofocal Lens
Surgeons are very familiar with its performance, and numerous studies have demonstrated its safety and effectiveness, showing good, reliable results for most ...
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