Treatment Trials

162 Clinical Trials for Various Conditions

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ENROLLING_BY_INVITATION
Post-market Clinical Follow-up Study of Alcon PRECISION1™ Spherical and PRECISION1™ for Astigmatism Soft Contact Lenses
Description

The purpose of this study is to assess long term performance and safety of verofilcon A soft contact lenses in a real-world setting in a population of 7 years or older having at least 1 year of verofilcon A (sphere or toric) contact lens wear in a daily wear and daily disposable modality.

COMPLETED
T30 for Astigmatism in Digital Device Users
Description

This study aims to determine if Total30 lenses for astigmatism can be successfully fit in participants who are heavy digital device users.

COMPLETED
Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Acuvue Oasys 1-Day for Astigmatism Contact Lenses
Description

Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double-masked (subject and investigator), repeated measures insertion study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria, subjects will be dispensed study lenses according to unique randomization tables that will be provided to each Investigator. If study eligibility is met, subjects will have lenses inserted in random, successive order. Subjects will be receiving each of the study lens types once, in a randomized order. The subject will wear each of the study contact lenses for approximately 10 minutes.

Conditions
COMPLETED
Total30 for Astigmatism Contact Lenses
Description

Determine if Total30 for Astigmatism contact lenses (CLs) provide a comfortable wearing experience all day. CL discomfort affects most CL wearers with discomfort consistently topping the reasons why established CL wearers drop out of CLs. In fact, studies have consistently found that the frequency of CL dropout is around 20% with this dropout frequency staying relatively stable over the past 20 plus years. This static frequency of CL dropout is surprising since there have been a number of dramatic soft CL innovations during this time frame (e.g., widely available daily disposable CLs, silicone hydrogel CL materials with high oxygen transmissibility, new CL surface coatings).

COMPLETED
Subjective Wearing Experience of the Total30 for Astigmatism Lens Among Satisfied Biofinity Toric Lens Wearers
Description

To subjectively evaluate wearing experience in the T30fA lens among subjects who were already satisfied with their Biofinity Toric lenses.

Conditions
TERMINATED
Comparison of Contoura Vision Outcomes Programmed Using the Manifest Refraction Verses Using Phorcides Planning Software in Patients With Oblique Astigmatism
Description

The objective is to compare the percentage of monocular UDVA -0.1 logMAR (20/16) outcomes for each planning strategy (Phorcides and manifest refraction) at the 3-month post operative visit.

COMPLETED
Success of Dailies Total1 for Astigmatism Contact Lenses in Patients That Have Previously Failed With Toric Contact Lenses
Description

The objective is to determine the percentages of past toric CL wearers (who dropped out of contact lens wear due to dissatisfaction with comfort or vision) who are satisfied with the comfort and vision of DT1fA contact lenses.

Conditions
UNKNOWN
Astigmatism Management With Iris-registration Guided Corneal Relaxing Incisions or Toric IOLs During Cataract Surgery
Description

Most of the patients presenting for cataract surgery also have pre-existing corneal astigmatism which if left uncorrected can adversely affect visual and refractive outcomes after cataract surgery. Pre-existing astigmatism at the time of cataract surgery can be corrected by either corneal relaxing incisions or implantation of toric IOLs. While the safety and efficacy of these procedures are well established, there are various challenges associated with these techniques that surgeons need to overcome to achieve good outcomes postoperatively. The use of iris registration technology that automatically compensates for cyclotorsion has the potential to improve the alignment accuracy of CRI or toric IOLs. The Cassini Ambient and Catalys Femtosecond Laser incorporate this technology to help cataract surgeons accurately align toric IOLs on the intended axis of implantation or accurately place CRI on the intended meridian. The present study is aimed at evaluating the efficacy of astigmatism correction during femtosecond laser-assisted cataract surgery with Catalys femtosecond laser. The patients will either undergo iris registration guided CRIs or iris registration guided alignment of toric IOLs.

COMPLETED
Performance of Dailies Total1® Contact Lenses for Astigmatism in Symptomatic Habitual Reusable Toric Lens Wearers
Description

To subjectively evaluate Dailies Total1® contact lenses for astigmatism (DT1fA) performance compared to other common weekly/monthly contact lenses in symptomatic patients.

Conditions
COMPLETED
1-Week Dispensing Evaluation of Kalifilcon A Toric Contact Lenses Compared to Ultra for Astigmatism
Description

Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated measures, dispensing study. All subjects will be seen for a Screening/Baseline Visit at which informed consent will be obtained and eligibility will be assessed.

COMPLETED
APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism
Description

Vision and comfort, both objective and subjective, will be assessed for single vision contact lens wearers for either the APIOC™ for Presbyopia or the APIOC™ for Presbyopia Astigmatism contact lenses.

COMPLETED
APIOC Sphere and APIOC Astigmatism
Description

Vision and comfort, both objective and subjective, will be assessed for single vision contact lens wearers for either the APIOC™ Sphere or the APIOC™ Astigmatism contact lenses.

COMPLETED
Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism
Description

A cataract is a clouding of the lens that occurs naturally with age. Cataract surgery involves removal of the cloudy lens and replacement with an artificial one. A special laser (femtosecond laser) is now being used to help make cataract surgery safer and more accurate . The femtosecond laser can also be used to correct astigmatism, an irregular curvature of the cornea, at the time of cataract surgery through a procedure called astigmatic keratotomy (AK). This study is gathering information about the specific laser settings that are used to perform astigmatic keratotomies (AK) during cataract surgery. This information will be used to improve the outcomes of patients that receive cataract surgery with astigmatic keratotomies in the future.

COMPLETED
Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism
Description

The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism.

COMPLETED
Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism
Description

Comparing Test Lens for Astigmatism Soft Contact Lens (Test) to 1-Day Control for Astigmatism contact lenses (Control).

Conditions
COMPLETED
Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3
Description

It is a common clinical practice to leave small amounts of astigmatism uncorrected in contact lens wearers. Therefore, some drivers who have astigmatism and wear contact lenses may experience blur while driving. The purpose of this study is to determine if correcting small amounts of astigmatism with contact lenses will improve driving safety.

Conditions
COMPLETED
Evaluating and Improving Functional Driving Vision of Patients With Astigmatism
Description

Small amounts of astigmatism are often uncorrected in contact lens wearers. The effect with respect to driving is unknown, but it could threaten safe operation of a motor vehicle, especially under conditions such as nighttime driving when visual abilities are highly challenged. This study measures driving-specific visual abilities and simulated driving performance in participants with astigmatism who either have or do not have their astigmatism corrected. The primary hypothesis is that at a tactical level, contact lenses correcting for astigmatism will result in safer driving performance overall. The secondary hypothesis is that at an operational level, contact lenses correcting for astigmatism will result in better driving-specific visual performance.

Conditions
COMPLETED
A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens
Description

This study was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens. The study results were not used for design validation of the investigational product.

Conditions
COMPLETED
Correction of Myopia Wtih or Without Astigmatism Using the VisuMax™ Femtosecond Laser
Description

The objective of this clinical trial is to evaluate the safety and effectiveness of the Carl Zeiss Meditec VisuMax™ Femtosecond Laser lenticule removal procedure for the reduction or elimination of myopia from ≥ -1.00 D to ≤ -10.00 D with ≤ -3.00 D cylinder (myopia with or without astigmatism) and MRSE ≤ -11.50 D.

COMPLETED
Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism
Description

Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.

Conditions
COMPLETED
Corneal Power, Astigmatism, and Aberration Changes After LASIK
Description

The primary goal of the study is to determine if Optical Coherence Tomography (OCT) measurement of corneal power and astigmatism is more accurate than conventional Placido-ring corneal topography. A second goal is to evaluate OCT-based epithelial thickness mapping. The postoperative epithelial thickness variation will be used to calculate refractive effects and calibrate the smoothing parameter in the mathematical model relating corneal mean curvature and epithelial thickness. A third goal is to assess the repeatability of OCT measurements. A fourth goal is to develop a method of estimating the focusing power, astigmatism, and HOA of the crystalline lens based on measurements of the lens' anterior and posterior capsular topographies and positions with the ultrahigh-speed MIT OCT prototype.

COMPLETED
Hydrophobic Acrylic Toric IOL Designed to Reduce the Effects of Preoperative Corneal Astigmatism
Description

The investigational enVista IOL, Model MX60Tis equipped with toric optics and axis marks on the posterior surface to minimize the possibility of surgically induced astigmatism.

Conditions
COMPLETED
Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism
Description

To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.

Conditions
COMPLETED
Corneal Astigmatism Measurement Study
Description

To assess which commercially available measurement device is most accurate in measuring low (\< 1.0 D) degrees of corneal astigmatism.

Conditions
RECRUITING
Evaluation of Wear Experience With a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers With Astigmatism
Description

This open-label study is of adults with astigmatism who have never worn contact lenses. Subjects will be fit into a one week planned-replacement contact lenses and will wear lenses for approximately 3 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.

COMPLETED
Evaluation of ACUVUE® OASYS 1-Day for Astigmatism Contact Lenses With Alternative Lidstock
Description

This will be a single-visit, randomized, double-masked, bilateral wear, non-dispensing, 2-sequence × 2-period crossover study to evaluate subject reported ocular symptoms.

RECRUITING
Safety and Effectiveness of the TENEO 317 Model 2 (1.28 US) Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Hyperopia With or Without Astigmatism
Description

This will be a multicenter, prospective, open label, non-randomized, single arm 12 month study, evaluating the safety and effectiveness of the TECHNOLAS TENEO 317 Model 2 (Software version "1.28 US") excimer laser when used in LASIK surgery to treat hyperopia with or without hyperopic astigmatism. Both eyes of a subject may be enrolled so long as both eyes meet all inclusion/exclusion requirements. Analysis of the primary effectiveness endpoint will be completed at refractive stability.

Conditions
COMPLETED
Evaluation of ACUVUE OASYS® 1-Day for Astigmatism Lenses Produced on a New Manufacturing Line
Description

This is a bilateral, dispensing, randomized, controlled, double-masked, 2×2 cross-over study to evaluate the clinical performance of ACUVUE OASYS® 1-Day for Astigmatism contact lenses produced on a recently qualified manufacturing line.

Conditions
ACTIVE_NOT_RECRUITING
Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism
Description

Aberrations are the spreading of light from a point focus. Aberrations of the eyes can be objectively evaluated with a wavefront aberrometer. Lower order aberrations such as defocus and astigmatism can be corrected with glasses and traditional/disposable soft contact lenses. Patients with ectatic corneal disease, such as keratoconus, or irregular astigmatism cause by surgery, trauma or disease, experience vision that is unlikely to be adequately corrected with glasses or disposable soft contact lenses due to higher order aberrations (HOA). HOA's cause halos, flare, glare, starbursts, doubling, smearing or ghosting of vision. Specialty contact lenses, such as scleral lenses, can be used to mask the irregularity of the cornea, reducing HOA's and improving vision. In many patients the resultant vision, though improved, still has some level of residual HOA's affecting the quality of vision. Custom scleral lenses with customized wavefront guided optics can be used to reduce residual HOA's and improve vision further. These lenses have been referred to as higher order aberration correcting scleral lenses or HOA correcting sclerals and wavefront guided scleral lenses or WFG sclerals.

COMPLETED
A Study With Technolas® TENEO 317 Model 2 Excimer Laser to Treat Participants With Myopia or Myopic Astigmatism
Description

The primary objective of this study is to collect safety and effectiveness data for the Technolas Teneo 317 Model 2 excimer laser for LASIK correction in participants with myopia and myopic astigmatism.