Clinical Research Directory

Post Market Clinical Evaluation of Clareon PanOptix Pro and Clareon PanOptix Pro Toric IOLs

The purpose of this study is to collect safety and performance data on two approved intraocular lenses (IOLs). This study will be conducted in participants who require cataract surgery in both eyes. The IOLs are designed to provide vision at far, arm's length, and near.

Evaluation of Functional Superiority of the Morrow eProgressive

Presbyopia is a common age-related condition where the eye loses its ability to focus on nearby objects, typically from around age 45. The standard correction is progressive addition lenses (PALs), but these have limitations: narrow viewing zones, peripheral distortion, and the need for unnatural head movements, which can affect comfort and safety. Morrow has developed an electronically adjustable progressive lens (Morrow eProgressive) that dynamically adapts its optical zones. This CE-marked device is already commercially available. This study compares its functional performance against standard PALs. Approximately 50 adults (≥45 years) will participate at three sites (Belgium and Italy). Each participant wears both glasses types for three weeks each, in random order. Researchers will measure head and eye movements during reading tasks, stair descent performance, and visual comfort via a questionnaire. Participants will also indicate their overall lens preference.

Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses

This is a 6-visit, single-masked, multi-site, 2×3 crossover, randomized-controlled, dispensing clinical trial to evaluate visual acuity.

Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses

This single-center, randomized, double-blind, crossover clinical trial aims to compare the volumetric visual fields provided by two occupational progressive addition lenses (OPLs) optimized for intermediate and near vision in presbyopic patients. The study evaluates Vimax Zoom 1.5 FWD 4 m and Vimax PC 1.5 FWD 4 m lenses and Vimax Fit FRM, all of them with plano distance power and a +2.00 D near addition, in order to determine differences in the extent of clear vision at multiple working distances. Participants will undergo a comprehensive optometric examination including medical and ocular history, visual acuity assessment, accommodative amplitude measurement, autorefraction, interpupillary distance measurement, ocular motility evaluation, confrontation visual fields, Amsler grid testing, and binocular vision assessment. Visual field measurements will then be performed using both study lenses under standardized conditions. Subjects will be instructed to maintain a fixed head position while identifying optotypes located at distances of 4 m, 2 m, 1.33 m, 80 cm, 40 cm, and 25 cm. Both lenses will be tested in random order under masked conditions so that neither participants nor investigators know which lens design is being evaluated during each phase. At least 23 presbyopic participants are expected to be enrolled. The study procedures are non-invasive and are anticipated to be completed in a single one-hour visit, although additional sessions may be scheduled if necessary. No significant risks are expected beyond possible transient visual fatigue associated with the duration of testing. The primary objective is to determine which occupational progressive lens design provides a greater spatial volume of clear vision and wider horizontal and vertical visual fields at different intermediate and near distances. The findings may contribute to improving personalized recommendations of occupational lenses according to patients' visual demands and working distances.

Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses

This single-center, randomized, double-blind, crossover clinical trial aims to compare the volumetric visual fields provided by two occupational progressive addition lenses (OPLs) optimized for intermediate and near vision in presbyopic patients. The study evaluates Vimax PC 1.5 FWD 133 cm and Vimax PC 1.5 FWD 200 cm lenses and Vimax Fit FRM, all of them with plano distance power and a +2.00 D near addition, in order to determine differences in the extent of clear vision at multiple working distances. Participants will undergo a comprehensive optometric examination including medical and ocular history, visual acuity assessment, accommodative amplitude measurement, autorefraction, interpupillary distance measurement, ocular motility evaluation, confrontation visual fields, Amsler grid testing, and binocular vision assessment. Visual field measurements will then be performed using both study lenses under standardized conditions. Subjects will be instructed to maintain a fixed head position while identifying optotypes located at distances of 4 m, 2 m, 1.33 m, 80 cm, 40 cm, and 25 cm. Both lenses will be tested in random order under masked conditions so that neither participants nor investigators know which lens design is being evaluated during each phase. At least 23 presbyopic participants are expected to be enrolled. The study procedures are non-invasive and are anticipated to be completed in a single one-hour visit, although additional sessions may be scheduled if necessary. No significant risks are expected beyond possible transient visual fatigue associated with the duration of testing. The primary objective is to determine which occupational progressive lens design provides a greater spatial volume of clear vision and wider horizontal and vertical visual fields at different intermediate and near distances. The findings may contribute to improving personalized recommendations of occupational lenses according to patients' visual demands and working distances.

Clinical Trial With Artiflex Presbyopic (Artiplus)

The purpose of this clinical trial is to evaluate the effectiveness and safety of the multifocal Artiflex Presbyopic (Artiplus) intraocular lens.

VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial

The primary study objective is to evaluate the safety and effectiveness of the VisAbility™ Micro Insert System for improvement in binocular distance corrected near visual acuity in presbyopic patients.

Contralateral Claims Study of Clareon Vivity Pro

The purpose of this study is to test new versions of Clareon Vivity Pro intraocular lenses (IOLs) by comparing them to currently marketed IOLs.

Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus

The purpose of this clinical study is to evaluate the effectiveness of the NOA lens, a custom-made scleral contact lens developed by Azalea Vision BV, in improving visual quality for individuals with keratoconus and presbyopia. This clinical study investigates a new lens design featuring a specific central aperture (opening) intended to enhance image quality by increasing depth of focus and reducing optical aberrations. The NOA lens serves as a functional prototype for future "smart lens" technology, specifically the ALMA Smart Lens. The study aims to determine if this specialized lens provides a solution for patients whose visual needs are not fully met by conventional glasses or contact lenses. The investigation will compare a standard refractive scleral lens (Type 1) against the aperture-integrated lens (Type 2) to validate the "pinhole effect" in improving vision and reducing higher-order aberrations.

Phase 3 Efficacy Study of LNZ100 & LNZ101 for the Treatment of Presbyopia

Phase 3 Efficacy Study to evaluate the Safety and Efficacy of LNZ100 \& LNZ101 for the Treatment of Presbyopia

Clinical Evaluation of Visual Performance, Spectacle Independence, and Patient Satisfaction With TECNIS PureSee Mini-Monovision and TECNIS PureSee-TECNIS Odyssey Mix-Match

The purpose of the study is to evaluate the binocular clinical endpoints of distance, intermediate, and near vision and patient reported outcomes utilizing mini-monovision versus mix-match approaches for the correction of presbyopia with intraocular lenses.

Presbyopic Wear Experience With Multifocal Lenses Compared to Single Vision Lenses and Reading Glasses

The purpose of the study is to assess participant experience when wearing multifocal contact lenses compared to spherical contact lenses with reading glasses.

Evaluation of Safety and Effectiveness of an IOL With a Virtual Aperture Optic

Cataracts are cloudy areas in the lens of the eye that can cause changes in vision. Symptoms of cataracts include cloudy or fuzzy vision and sensitivity to glare. Cataract extraction with Intraocular lens (IOL) implantation is the most commonly performed surgical procedure in the world. Presbyopia affects almost everyone over the age of 50. With age, the natural crystalline lens loses its ability to change shape, or accommodate, to focus on near distances. Thus, individuals with excellent distance vision will still need to wear spectacles for near tasks such as reading, and intermediate tasks such as computer work.

Clinical Applications of Advanced Ophthalmic Imaging

The purpose of this study is to determine the clinical application of advanced ophthalmic imaging devices such as optical coherence tomography (OCT), retinal function imager (RFI), slit-lamp biomicroscopy (SLB), PERG in diseased eyes and normal controls. There are two phases in this study. The first phase is an observational phase which studies the eye in various conditions. The second phase is an interventional phase which studies the changes in the eyes after taking an over-the-counter medical food (Ocufolin) for 6 months.

Comfort and Vision With TOTAL30 Multifocal Lenses

This study is a single-arm, prospective, observational study conducted at one site to evaluate the comfort and vision of the TOTAL30 Multifocal (T30MF) contact lenses over the course of long wear days. The study will assess the proportion of positive subjective Visual Analog Scale (VAS) assessments of comfort and vision at 10, 12, 14, and 16 hours of wear on Days 1, 7, 14, and 30. Additionally, the study will explore subjective assessments of lens comfort using the CLDEQ-8 survey and measure logMAR visual acuity at both distance and near at Visit 1, Visit 2, and after 1 month of lens wear. Participants will undergo three site visits, with at-home surveys conducted at specified intervals to gather real-time data on comfort and vision.

Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix

The purpose of this Post-Market Clinical Follow-up study is to describe the long-term safety and performance of the Clareon Vivity and Vivity Toric and Clareon PanOptix and PanOptix Toric IOLs.

Evaluate the Efficacy and Safety of CTO0307 in Adults With Presbyopia

This study was to compare the presbyopia correction effect between the treatment group and the control group, evaluated by the proportion of patients who achieved an improvement of 3 lines or more in mesopic binocular DCNVA at post-dose after 4 weeks of administration of the investigational product.

PROductivity Study of Presbyopia Elimination in Rural-dwellers III

The investigators will conduct an embedded mixed methods study in which the primary approach is a randomized controlled trial (RCT), and the secondary or embedded approach is a descriptive qualitative study. The aim of the RCT is to assess the impact of presbyopic correction on workplace productivity and retention in the textile industry in a low middle-income country. Additional qualitative data will be collected to enhance understanding of factors linked to reasons why enrolled sew-ers left their job during the study. Participants will be textile workers aged 30 years and above with uncorrected presbyopia who are employed by Shahi Exports Private Limited in Karnataka, India.

PROductivity Study of Presbyopia Elimination in Rural-dwellers II

The investigators will conduct a randomized-controlled trial. The participants will be textile workers aged 35 years and above with uncorrected presbyopia who are employed by a single Indian garment manufacturer - employed by Shahi Exports Private Limited, Karnataka, India - at facilities equipped to measure individual productivity. PROSPER II will assess the impact of free reading glasses on productivity for workers in a textile factory.

Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia

Safety and efficacy of POS in participants with presbyopia

Transforming Households With Refraction and Innovative Financial Technology

The aim of the proposed Randomised Clinical Trial (RCT) is to assess the impact of presbyopia correction and basic digital financial training on greater adoption and use of digital financial services (primary outcome) and other welfare impacts (secondary outcomes)) for safety-net beneficiaries in Bangladesh. Trial participants will be Old Age Allowance (OAA) and Widows Allowance (WA) beneficiaries who regularly receive payments as part of a government safety net program for the very poor. The primary objective of the THRIFT trial is to assess whether the combined complementary intervention of providing free eyeglasses and basic digital financial services training in the use of mobile phones to recipients of government OAA and WA safety-net payments can lead to greater financial inclusion and improved quality of life. THRIFT's primary outcome is the adoption and effective use of the DFS platform in receiving digital OAA and WA transfers using the mobile banking platform, as measured by the difference between the treatment and control groups. The secondary outcomes analysed under the THRIFT trial will be: total data consumption, independent use of the mobile banking application, purchase of eyeglasses (for control group members), access to medication and healthcare, subjective well-being, mobility, social connectedness, percentage of household consumption, reasons for using or avoiding smartphone based DFS, and decision-making power within the household.

1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for Presbyopia

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/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be fit and dispensed study lenses according to unique randomization schedules that will be provided to each Investigator If vision is unsatisfactory in the original dispensed lenses, additional lens powers may be trialed.

A New Successful Approach for Emmetropic Presbyopic Patients Using Intrastromal Pocket With Smile Module

Presbyopia is physiological insufficiency of accommodation associated with the aging of the eye that results in progressively worsening ability to focus clearly on close objects.Though presbyopia is a normal change in our eyes as we age, it often is a significant and emotional event because it's a sign of aging that's impossible to ignore and difficult to hide. This defect is usually corrected by using glasses with bifocal power of suitable focal lengths. But some patients don't want to use glasses for correction. In our study purpose is to show that near vision improves and patient satisfaction increases by preparing an intrastromal pocket for emmetropic patients with near vision problems using the SMILE module.

Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia

The objectives of this study are: To evaluate the safety and efficacy of Nyxol alone and with adjunctive low dose pilocarpine to improve distance-corrected near visual acuity (DCNVA) in subjects with presbyopia.