Treatment Trials

31 Clinical Trials for Various Conditions

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COMPLETED
Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes
Description

Current visual outcomes expectations of cataract patients are similar to those of refractive surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision activities. Some may have already enjoyed freedom from glasses and would like to continue after the cataracts are removed. Different options are available. These options include: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocals and extended depth of focus (EDOF) IOLs. In a previous study, the visual outcomes of the EDOF Toric IOL were evaluated when both eyes were targeted for plano and when the non-dominant eye was set for a small residual myopic error (-0.50 D) or nanovision in patients with astigmatism. The nanovision approach, appeared to provide similar binocular acuity at distance and intermediate but better acuity at near. The purpose of this study is to evaluate the visual outcomes of an EDOF IOL when combined with a multifocal IOL with a +3.25 D add in patients with or without astigmatism undergoing routine cataract surgery.

COMPLETED
Symfony Toric Intraocular Lens Visual Outcomes
Description

In July 2016, the FDA approved an extended depth of focus (EDOF) IOL (Tecnis Symfony, Abbott Medical Optics) helping to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery. It is available in both a non-toric version and a toric version for patients with astigmatism. The difference between this lens and the multifocal (MIOL) counterpart is that the EDOF, similarly to a monofocal IOL, has one focal point (elongated in the EDOF) while the multifocals have 2 focal points; therefore, having less of a halo and glare problem. Pivotal trial results where Symfony was compared to a monofocal IOL showed similar uncorrected distance visual acuity (UCDVA), better intermediate (77% vs. 34% 20/25 uncorrected intermediate visual acuity - UCIVA) and near vision (Symfony patients were able to read two additional, progressively smaller lines compared to the monofocal IOL).A One potential disadvantage of the EDOF IOL compared to a MIOL is the visual performance at near.B One option to deal with this potential shortcoming is to set the non-dominant eye for a small residual myopic error (-0.50 D)C what is referred to as nano-vision or mini mono-vision.

COMPLETED
Immediate Simultaneous Bilateral Cataract Surgery
Description

To evaluate the safety and efficacy of treating visually significant bilateral cataract with the newer technique of Immediate Simultaneous Bilateral Cataract Surgery (ISBCS) versus the conventional technique of Delayed Sequential Bilateral Cataract Surgery (DSBCS) in a select patient population.

COMPLETED
Symfony/Synergy IOL Combination Outcomes
Description

Current visual outcomes expectations of cataract patients are similar to those of refractive surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision activities. Some may have already enjoyed freedom from glasses and would like to continue after the cataracts are removed. Different options are available. These options include: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocals and extended depth of focus (EDOF) IOLs. In a previous study that evaluated the visual outcomes of an EDOF IOL when combined with a multifocal IOL with a +3.25 D add in patients with or without astigmatism undergoing routine cataract surgery showed good outcomes with high patient satisfaction and less dependance on glasses for intermediate and near activities. As technology evolves, new lens models are available in the market. The purpose of this study is to evaluate the latest EDOF and a hybrid multifocal lenses when combined.

COMPLETED
ACRYSOF® Toric NATURAL T9 Intraocular Lens (IOL)
Description

The purpose of this study is to describe rates of spatial distortions related to intraocular lens (IOL) misalignment for ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 when implanted bilaterally into the capsular bag following phacoemulsification in adult patients with bilateral cataract and regular corneal astigmatism. Subjects were implanted with the Model SN60T9 in the first operative (study) eye and either Model SN60T9 or Model SN60T8 in the second operative eye.

COMPLETED
Cerebrotendinous Xanthomatosis (CTX) Prevalence Study
Description

Iiopathic bilateral cataracts occur in many children with Cerebrotendinous Xanthomatosis (CTX) so the opportunity to use contact with health care providers in connection with pediatric cataract evaluation and treatment is a promising avenue for disease detection and prevention.

COMPLETED
Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL
Description

The objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).

Conditions
COMPLETED
Visual Function After Implantation of Bilateral AcrySof® Toric Natural Intraocular Lens
Description

The purpose of this study is to evaluate the effect that placement and power of the AcrySof Toric has on post-operative visual acuity and spectacle independence for distance vision. This will be determined by comparing manifest refraction pre-operatively and post-operatively and by evaluating the rotational stability of the lens over time.

Conditions
COMPLETED
Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1
Description

The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric +3.0 Intraocular Lens (IOL).

Conditions
ACTIVE_NOT_RECRUITING
Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study
Description

The goal of this pilot clinical trial comparing two different sedation approaches for cataract surgery is to assess patient satisfaction, the quality of recovery, and surgical outcomes as well as to evaluate the overall feasibility and acceptability of the study protocol for the purpose of planning a larger clinical trial. Participants will be asked to respond to several surveys throughout the study on their experience and to assess outcomes of interest.

RECRUITING
Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients
Description

Millions of people have undergone laser vision correction surgery and are motivated to continue with spectacle independence as they develop presbyopia (gradual loss of your eyes' ability to focus on nearby objects)and cataract. However, having a history of refractive surgery, poses challenges in the selection of the IOLs and can lead to visual outcomes that are unpredictable. Data from an international registry and single prospective study show that Vivity IOL provided effective distance, intermediate and near vision in eyes with previous LASIK with minimal effects on day vision associated with the surgery. The purpose of this study is to evaluate the clinical outcomes of post-myopic refractive surgery patients implanted with the Clareon Vivity/Vivity Toric lenses

RECRUITING
A Prospective, Randomized, Subject and Vision-assessor Masked, Multicenter Study Comparing Bilateral Clareon PanOptix, Bilateral Clareon PanOptix Pro, and Mixed Clareon PanOptix Pro/Vivity Intraocular Lens Implantation in Cataract Subjects
Description

Prospective, randomized, multicenter, multi-arm, subject and vision-assessor-masked, two stage study with Stage 1 as a three-arm initial enrollment period, followed by Stage 2 as a head-to-head study refined based on the Stage 1 data.

Conditions
COMPLETED
Clinical Outcomes With Bilateral Implantation of Odyssey IOLs
Description

This study is a single center, ambispective study of visual outcomes after successful bilateral cataract surgery. Subjects will be assessed at least 3 months postoperatively at a single visit. Clinical evaluations will include administration of the AIOLIS and OSDI questionnaires, as well as measurement of visual acuities at distance, intermediate, and near.

Conditions
COMPLETED
Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens
Description

To evaluate visual outcomes and quality of vision following bilateral implantation of the Clareon PanOptix intraocular lens (IOL) targeted for emmetropia.

Conditions
UNKNOWN
Prospective Evaluation and Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants
Description

The purpose of this study is to evaluate the AcrySof PanOptix Intraocular Lens (IOL) for binocular distance corrected near visual acuity (DCNVA) compared to TECNIS Synergy IOL. Presbyopia correcting diffractive intraocular implants (extended depth of focus, multifocal, and trifocal) provide cataract and refractive surgeons with an effective treatment means for allowing patients to experience increased spectacle independence post-cataract surgery.

Conditions
COMPLETED
AcrySof® Bilateral PanOptix(R) Spectacle Freedom and Patient Satisfaction Study
Description

The objective of this study is to assess the spectacle independence of patients receiving the AcrySof® Panoptix® Intraocular lens (IOL) after uneventful cataract surgery.

Conditions
TERMINATED
Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses
Description

The objective of this study is to demonstrate the correlation of near vision and changes in higher order aberrations following lens extraction and to characterize the defocus curves of Crystalens® AO™ intraocular lens (IOL) versus the monofocal aspheric SofPort® LI61AO IOL in adults.

Conditions
COMPLETED
Visual Performance of Bilateral AcrySof ReSTOR Aspheric +4
Description

Determine the clinical visual outcomes following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) and to demonstrate what percentage of the subjects obtain spectacle freedom.

Conditions
COMPLETED
A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)
Description

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece.

Conditions
COMPLETED
Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses
Description

The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR intraocular lenses (IOLs) 6 months post cataract surgery.

Conditions
TERMINATED
Multifocals and Accommodating/Bilateral Implantation of Different Multifocal Intraocular Lens (IOLs)
Description

The purpose of this study is to evaluate vision at different distances (far (13 ft), intermediate (2.0 ft) and near (13 to 15 in)) with and without the patient's glasses (if the patient wears them), range of vision (the difference between the farthest distance and the closest distance that the patient can comfortably read 20/25 of the near card), and patient satisfaction (how satisfied/happy is the patient with their vision) following bilateral implantation of different multifocal IOLs after routine phacoemulsification. The patients are being asked to participate in this study because you have had cataract surgery and have received one of the IOLs implanted: ReSTOR +4.0 D, ReSTOR +3.0 D, Crystalens, and/or ReZoom. The investigator in charge of this study is Dr. Helga Sandoval. This study is being conducted at Storm Eye Institute at the Medical University of South Carolina and will involve approximately 50 volunteers.

Conditions
COMPLETED
Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL
Description

This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.

Conditions
WITHDRAWN
Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL
Description

The objective of the study is to compare the visual outcomes of three aspheric monofocal intraocular lenses after cataract surgery - ACRYSOF® IQ, Tecnis® and Akreos® MI60.

Conditions
COMPLETED
Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
Description

The purpose of the study is: * to compare visual parameters (Subjective refraction and Visual Acuity (VA)) and safety (tilt, decentration and posterior chamber opacification (PCO)) in a prospective series of 40 patients after bilateral implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT) * to assess patient satisfaction before and after implant

Conditions
COMPLETED
Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3
Description

A prospective evaluation of the visual parameters in a series of patients bilaterally implanted with AcrySof ReSTOR +3 Intraocular Lens (IOL).

Conditions
COMPLETED
Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis or Acri.LISA
Description

This is a study to compare visual outcomes of subjects bilaterally implanted w/ReSTOR to subjects bilaterally implanted with the Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL

Conditions
UNKNOWN
AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL
Description

The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.

Conditions
COMPLETED
Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).
Description

Randomized contralateral clinical trial with single piece (Model SN60WF) vs. three piece (Model MA60AC) AcrySof Intraocular Lenses (IOLs) on development of Posterior Chamber Opacifiation (PCO).

Conditions
WITHDRAWN
A Study of Levofloxacin Ocular Implant in Patients Undergoing Routine Bilateral Cataract Surgery
Description

Open label controlled interventional study in eyes in up to 12 subjects (24 eyes) scheduled for uncomplicated bilateral cataract surgery on separate days.

Conditions
UNKNOWN
Dextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With PCIOL.
Description

Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.