Cataract SenileNCT06264232
AT ELANA 841P Posterior Chamber Intraocular Lens for Correction of Aphakia Following Cataract Removal
A study testing Cataract Surgery in people with Cataract Senile, run by Carl Zeiss Meditec, Inc. at 14 sites in United States.
Trial summary
The goal of this clinical trial is to demonstrate the safety and effectiveness of the full visual range AT ELANA 841P IOL when used to treat adult patients having cataract surgery. Subjects will be randomly selected to receive a pair of IOLs, either the AT ELANA 841P or CT LUCIA 621P lens design. Read more about this study
- Who is it for?
- Ages 22 to 100 years
- Conditions the study is for
- Cataract Senile
- What is being tested?
- Cataract Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 14 sitesUnited States
- Study dates
- 12 Jul 2024to 1 Dec 2025
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, 22 years of age or older at the time of study enrollment
- Bilateral cataractous lens changes as demonstrated by best corrected distance visual acuity of 0.30 logMAR (20/40) or worse either with or without a glare source present (e.g., Brightness Acuity Tester) for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated
- Best corrected distance visual acuity projected to be better than 0.20 logMAR (better than 20/30) after cataract removal and IOL implantation
- Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D) in both operative eyes
- Clear intraocular media other than cataract
- Contact lens wear is to be discontinued two (2) weeks for soft contact lenses both daily and extended wear; and ≥ 30 days for rigid gas permeable lenses prior to preoperative biometry and keratometry testing.
Show all 9Show fewer
- Calculated lens power within the available range
- Subject is willing to sign the IRB-approved informed consent form
- Subject is willing, able and has sufficient cognitive awareness to comply with examination procedures and schedule for follow-up visits
Who cannot join
- Presence of systemic disease that could increase the operative risk or confound the outcome, including but not limited to diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc.
- Ocular condition that may predispose for future complications, including but not limited to dry eye syndromes or symptoms, anterior segment pathology, glaucoma (uncontrolled despite intake of medication), history of cystoid macular edema, macular degeneration as confirmed by clinical examination and adjunct testing (e.g., OCT, FA)
- Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity, inflammation or edema; conditions including but not limited to active/inactive keratitis, keratoconjunctivitis, kerato uveitis, keratopathy, keratectasia
- Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject, including corneal transplants, retinal detachment, glaucoma surgeries, refractive laser procedures including but not limited to LASIK, limbal relaxing incision, Small Incision Lenticule Extraction (SMILE) etc.
- Use of or history of use of systemic medications with significant ocular side effects or any medications that could confound the outcome or increase subject risk (e.g., Tamsulosin Hydrochloride [Flomax] or other medications including anticholinergics or alpha-adrenergic blocking agents with similar side effects [e.g., small pupil/floppy iris syndrome], antimetabolites, etc.)
- Currently taking systemic steroids and/or planned on taking systemic steroids prior to operative visit and during the course of the investigation.
Show all 25Show fewer
- Subjects with diagnosed degenerative visual disorders, including but not limited to macular degeneration or other retinal disorders (such as diabetic retinopathy, diabetic macular edema, retinal detachment) that are predicted to confound outcomes or to cause future acuity loss to 0.20 logMAR or worse.
- Subjects with conditions that increase the risk of zonular rupture (e.g., pseudoexfoliation syndrome, Marfan's syndrome) during cataract extraction procedure that may affect the postoperative centration or tilt of the IOL
- Expected concomitant ocular procedure during cataract surgery or within the next 12 months (e.g., glaucoma surgery including implantation of MIGS, astigmatic correction surgery, penetrating keratoplasty [PK], laser-assisted in situ keratomileusis, SMILE etc.)
- Subjects who are expected to require retinal laser treatment within the next 12 months
- History of amblyopia or monofixation syndrome with poor stereoscopic vision
- Rubella, congenital, traumatic or complicated cataracts
- History of or current anterior or posterior segment inflammation, including but not limited to iritis or uveitis
- Microphthalmos or macrophthalmos
- Iris defects (e.g., aniridia)
- Optic nerve atrophy
- Keratoconus or Irregular astigmatism, as determined by topography
- Inability to perform keratometry, topography or biometry (including but not limited to cataract density, subject unable to focus for longer time etc.) or subjects with unstable keratometry, topography or biometry measurements
- Pathologic miosis caused by anterior segment pathology in the study eye (e.g., chronic uveitis, iritis, rubeosis iridis, neurological conditions such as multiple sclerosis, Argyle Robertson's pupil, acquired or congenital Horner´s syndrome, etc.)
- Pupil diameter less than 6 mm when fully dilated
- Pregnant, lactating at time of enrollment, or has another condition with associated fluctuation of hormones that could lead to refractive changes
- Subject whose freedom is impaired by administrative or legal order
- Concurrent participation in another drug or device investigation that could confound the outcome of this investigation
- Subjects unable to achieve keratometry stability after discontinuing contact lens wear
- Gonioscopic abnormalities
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Beverly Hills Institute of Ophthalmology
Beverly Hills, California, 90210
Chu Vision Institute
Bloomington, Minnesota, 55420
Cleveland Eye Clinic
Brecksville, Ohio, 44141
Cape Coral Eye Center
Cape Coral, Florida, 33904
Whitsett Vision Group
Houston, Texas, 77055
Texas Eye & Laser
Hurst, Texas, 76054
Eye Centers of Racine & Kenosha
Kenosha, Wisconsin, 53142
Carolina Eyecare Physicians, LLC
Mt. Pleasant, South Carolina, 29464
Mitchell C Shultz MD/Shultz Chang Vision
Northridge, California, 91325
Vance Thompson Vision-Nebraska
Omaha, Nebraska, 68137
Coastal Vision Medical Group
Orange, California, 92868
PNV Clinical Research
San Antonio, Texas, 78229
Vance Thompson Vision-South Dakota
Sioux Falls, South Dakota, 57108
Ophthalmology Consultants of St Louis
St Louis, Missouri, 63131
About this study
Official title: A Multi-center, Prospective, Randomized, Controlled Clinical Trial to Demonstrate the Safety and Effectiveness of the Full Visual Range AT ELANA 841P Posterior Chamber Intraocular Lens for Correction of Aphakia Following Cataract Removal
The goal of this clinical trial is to demonstrate the safety and effectiveness of the full visual range AT ELANA 841P IOL when used to treat adult patients having cataract surgery. Subjects will be randomly selected to receive a pair of IOLs, either the AT ELANA 841P or CT LUCIA 621P lens design. All patients will undergo surgery in both eyes, and they will receive follow up care for up to 6-months. During this time, all patients will undergo thorough eye exams at every study visit and complete questionnaires about their quality of vision post-surgery.
Read the detailed description
The goal of this clinical trial is to demonstrate safety and effectiveness of the full visual range AT ELANA 841P posterior chamber IOL when used to treat adult patients undergoing cataract surgery. In this study, all patients will be randomly assigned (using a 1 to 1 ratio) to receive either the investigational device: AT ELANA 841P trifocal IOL, or the commercially available, FDA-approved, control device: CT LUCIA 621P monofocal IOL.
There will be 286 adults, 22 years of age or older. All will be scheduled to undergo cataract surgery in both eyes; along with completing a 6-months follow-up. This clinical trial will take place at 14 clinical sites located throughout the United States.
Salus IRB will provide ethical oversight for this clinical trial, while Ora, Inc. is the CRO assisting the research sites with completing all required study activities.
This clinical trial is expected to be about 18-months long.
Each participant who provides their consent for study participation must meet the following visual criteria to qualify:
- Before Cataract Surgery: Best-Corrected Visual Acuity 20/40 or worse with or without glare present.
- Astigmatism of 1.0 diopter or less in both eyes
- After Cataract Surgery: Best-Corrected Visual Acuity is expected to be better than 20/30
Study Enrollment is anticipated to begin June 2024, and will last about 10-months. During this time, subjects will undergo cataract surgery in both eyes, and after surgery will attend about 8 follow-up visits spread over 6-months. At these visits each individual will have their vision thoroughly examined, and be asked to complete questionnaires about the quality of their vision.
Typical Assessments each participant will have at their study visits include:
- You will be asked about your current overall health and about any previous conditions or treatments you have had.
- Any medications you have taken, are taking now or have stopped taking while in the study will be recorded.
- Visual acuity and Subjective refraction (glasses prescription): your doctor will test your far vision with and without glasses.
- Biometry: the anatomy of your eye will be measured using a specialized instrument to calculate the recommended IOL power for your eyes.
- Pupil diameter: the study doctor will measure the size of your pupils.
- Intraocular pressure: numbing drops will be put in your eyes and your eye pressure will be measured by touching an instrument to your cornea, which is the clear front window of your eye. Since your eyes are numb, you should feel no pain during this procedure.
- Slit lamp examination: the front part of your study eye will be examined using a bright light and a special microscope called a slit lamp. Dilating drops could be put in your study eye to enlarge your pupil (the black circle in the center of the colored part [the iris] of the eye). The study doctor will use a magnifying lens and a bright light to examine your retina, which is the back of your eye. The effect of these drops will last approximately 4 -5 hours, and during that time, it is recommended that you should not drive a car or operate machinery.
- Dilated fundus (retina) examination: once the pupil is dilated, the study doctor will observe the back part of your eyes.
- Questionnaire: you will be asked to complete a questionnaire to collect information on any problems which involve your vision or feelings that you have about the condition of your vision.
Later in the study, these assessments will be performed for each participant:
- Contrast Sensitivity: a special device will be used to test how well you can differentiate objects on a bright background with different lighting conditions (Month 6 only).
- Defocus Curve: your study doctor will place different lenses in front of your eyes. This simulates how you would see at different distances without changing your position to the test chart. Your vision will be measured to determine how well you are able to see at each of the distances (Month 1, Month 6).
- Conditions
- Cataract Senile
- Being tested
- Cataract Surgery
- Keywords
- Cataract, Cataract Surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract SurgeryDevice
Bilateral removal of age related cataractous lenses with the implantation of intraocular lenses to improve visual acuity.
| Study group | Role | What they receive |
|---|---|---|
| AT ELANA 841P IOL | Experimental | Cataract Surgery to implant multifocal intraocular lenses Receives: Device: Cataract Surgery |
| CT LUCIA 621P IOL | Active comparator | Cataract Surgery to implant monofocal intraocular lenses Receives: Device: Cataract Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Outcome
Mean, monocular photopic logMAR best-corrected distance visual acuity (BCDVA) at 4 m for the first implanted eyes, at Month 6 (Visit 4).
Measured: Month 6
Primary Effectiveness Outcome
Mean, monocular photopic logMAR distance-corrected near visual acuity (DCNVA) at 40 cm, for the first implanted eyes at Month 6 (Visit 4)
Measured: Month 6
Primary Effectiveness Outcome
Mean, monocular photopic logMAR distance-corrected intermediate visual acuity (DCIVA) for the first implanted eyes at 66 cm, at Month 6 (Visit 4)
Measured: Month 6
Primary Effectiveness Outcome
Mean, monocular photopic logMAR distance-corrected visual acuity (DCVA) at 1 m (equal to -1 D defocus) and 50 cm (equal to -2 D defocus), for the first implanted eyes at Month 6 (Visit 4)
Measured: Month 6
Primary Effectiveness Outcome
Proportion of AT ELANA 841P IOL eyes achieving monocular photopic BCDVA 0.30 logMAR or better, for first implanted eyes in Full Analysis Set (FAS) and Best Case Set (BCS), at Month 6 (Visit 4)
Measured: Month 6
Primary Safety Outcome
Mean log monocular mesopic far contrast sensitivity (without glare at spatial frequency of 1,5, 3, 6, and 12 cycles/degree) for first implanted eyes in Best Case Set (BCS), at Month 6 (Visit 4)
Measured: Month 6
Primary Safety Outcome
Rate of secondary surgical interventions related to the optical properties of the lens for first implanted eyes, through 6 months.
Measured: Month 6
Primary Safety Outcome
Rate of Posterior Chamber IOL cumulative and persistent adverse events (AEs) listed in the ISO 11979-7:2024 Table E.2, for first implanted eyes, through 6 months.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start12 Jul 2024
- Primary completion3 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SenileStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
- Investigators
- Seth M Pantanelli, MD, Principal investigator, Penn State Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264232
- Sponsor's protocol ID
- AT ELANA 841P-BER-303-24
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Randomized, Controlled Clinical Trial to Demonstrate the Safety and Effectiveness of the Full Visual Range AT ELANA 841P Posterior Chamber Intraocular Lens for Correction of Aphakia Following Cataract Removal
- ClinicalTrials.gov ID
- NCT06264232
- Acronym / sponsor ID
- AT ELANA 841P-BER-303-24
- Conditions
- Cataract Senile
- Keywords
- Cataract, Cataract Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 16 Feb 2024 (actual)
- 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.
The goal of this clinical trial is to demonstrate the safety and effectiveness of the full visual range AT ELANA 841P IOL when used to treat adult patients having cataract surgery. Subjects will be randomly selected to receive a pair of IOLs, either the AT ELANA 841P or CT LUCIA 621P lens design. All patients will undergo surgery in both eyes, and they will receive follow up care for up to 6-months. During this time, all patients will undergo thorough eye exams at every study visit and complete questionnaires about their quality of vision post-surgery.
Detailed description
The goal of this clinical trial is to demonstrate safety and effectiveness of the full visual range AT ELANA 841P posterior chamber IOL when used to treat adult patients undergoing cataract surgery. In this study, all patients will be randomly assigned (using a 1 to 1 ratio) to receive either the investigational device: AT ELANA 841P trifocal IOL, or the commercially available, FDA-approved, control device: CT LUCIA 621P monofocal IOL.
There will be 286 adults, 22 years of age or older. All will be scheduled to undergo cataract surgery in both eyes; along with completing a 6-months follow-up. This clinical trial will take place at 14 clinical sites located throughout the United States.
Salus IRB will provide ethical oversight for this clinical trial, while Ora, Inc. is the CRO assisting the research sites with completing all required study activities.
This clinical trial is expected to be about 18-months long.
Each participant who provides their consent for study participation must meet the following visual criteria to qualify:
- Before Cataract Surgery: Best-Corrected Visual Acuity 20/40 or worse with or without glare present.
- Astigmatism of 1.0 diopter or less in both eyes
- After Cataract Surgery: Best-Corrected Visual Acuity is expected to be better than 20/30
Study Enrollment is anticipated to begin June 2024, and will last about 10-months. During this time, subjects will undergo cataract surgery in both eyes, and after surgery will attend about 8 follow-up visits spread over 6-months. At these visits each individual will have their vision thoroughly examined, and be asked to complete questionnaires about the quality of their vision.
Typical Assessments each participant will have at their study visits include:
- You will be asked about your current overall health and about any previous conditions or treatments you have had.
- Any medications you have taken, are taking now or have stopped taking while in the study will be recorded.
- Visual acuity and Subjective refraction (glasses prescription): your doctor will test your far vision with and without glasses.
- Biometry: the anatomy of your eye will be measured using a specialized instrument to calculate the recommended IOL power for your eyes.
- Pupil diameter: the study doctor will measure the size of your pupils.
- Intraocular pressure: numbing drops will be put in your eyes and your eye pressure will be measured by touching an instrument to your cornea, which is the clear front window of your eye. Since your eyes are numb, you should feel no pain during this procedure.
- Slit lamp examination: the front part of your study eye will be examined using a bright light and a special microscope called a slit lamp. Dilating drops could be put in your study eye to enlarge your pupil (the black circle in the center of the colored part [the iris] of the eye). The study doctor will use a magnifying lens and a bright light to examine your retina, which is the back of your eye. The effect of these drops will last approximately 4 -5 hours, and during that time, it is recommended that you should not drive a car or operate machinery.
- Dilated fundus (retina) examination: once the pupil is dilated, the study doctor will observe the back part of your eyes.
- Questionnaire: you will be asked to complete a questionnaire to collect information on any problems which involve your vision or feelings that you have about the condition of your vision.
Later in the study, these assessments will be performed for each participant:
- Contrast Sensitivity: a special device will be used to test how well you can differentiate objects on a bright background with different lighting conditions (Month 6 only).
- Defocus Curve: your study doctor will place different lenses in front of your eyes. This simulates how you would see at different distances without changing your position to the test chart. Your vision will be measured to determine how well you are able to see at each of the distances (Month 1, Month 6).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AT ELANA 841P IOL | Experimental | Device: Cataract SurgeryCataract Surgery to implant multifocal intraocular lenses |
| CT LUCIA 621P IOL | Active comparator | Device: Cataract SurgeryCataract Surgery to implant monofocal intraocular lenses |
Who may qualify
- Ages
- 22 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults, 22 years of age or older at the time of study enrollment
- Bilateral cataractous lens changes as demonstrated by best corrected distance visual acuity of 0.30 logMAR (20/40) or worse either with or without a glare source present (e.g., Brightness Acuity Tester) for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated
- Best corrected distance visual acuity projected to be better than 0.20 logMAR (better than 20/30) after cataract removal and IOL implantation
- Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D) in both operative eyes
- Clear intraocular media other than cataract
Key exclusion criteria (25 listed)
- Presence of systemic disease that could increase the operative risk or confound the outcome, including but not limited to diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc.
- Ocular condition that may predispose for future complications, including but not limited to dry eye syndromes or symptoms, anterior segment pathology, glaucoma (uncontrolled despite intake of medication), history of cystoid macular edema, macular degeneration as confirmed by clinical examination and adjunct testing (e.g., OCT, FA)
- Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity, inflammation or edema; conditions including but not limited to active/inactive keratitis, keratoconjunctivitis, kerato uveitis, keratopathy, keratectasia
- Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject, including corneal transplants, retinal detachment, glaucoma surgeries, refractive laser procedures including but not limited to LASIK, limbal relaxing incision, Small Incision Lenticule Extraction (SMILE) etc.
- Use of or history of use of systemic medications with significant ocular side effects or any medications that could confound the outcome or increase subject risk (e.g., Tamsulosin Hydrochloride [Flomax] or other medications including anticholinergics or alpha-adrenergic blocking agents with similar side effects [e.g., small pupil/floppy iris syndrome], antimetabolites, 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 |
|---|---|---|
| Cataract SurgeryBilateral removal of age related cataractous lenses with the implantation of intraocular lenses to improve visual acuity. | Device | AT ELANA 841P IOL, CT LUCIA 621P IOL |
Primary outcome
Primary Effectiveness Outcome
Time frame: Month 6
Mean, monocular photopic logMAR best-corrected distance visual acuity (BCDVA) at 4 m for the first implanted eyes, at Month 6 (Visit 4).
Primary Effectiveness Outcome
Time frame: Month 6
Mean, monocular photopic logMAR distance-corrected near visual acuity (DCNVA) at 40 cm, for the first implanted eyes at Month 6 (Visit 4)
Primary Effectiveness Outcome
Time frame: Month 6
Mean, monocular photopic logMAR distance-corrected intermediate visual acuity (DCIVA) for the first implanted eyes at 66 cm, at Month 6 (Visit 4)
Primary Effectiveness Outcome
Time frame: Month 6
Mean, monocular photopic logMAR distance-corrected visual acuity (DCVA) at 1 m (equal to -1 D defocus) and 50 cm (equal to -2 D defocus), for the first implanted eyes at Month 6 (Visit 4)
Primary Effectiveness Outcome
Time frame: Month 6
Proportion of AT ELANA 841P IOL eyes achieving monocular photopic BCDVA 0.30 logMAR or better, for first implanted eyes in Full Analysis Set (FAS) and Best Case Set (BCS), at Month 6 (Visit 4)
Primary Safety Outcome
Time frame: Month 6
Mean log monocular mesopic far contrast sensitivity (without glare at spatial frequency of 1,5, 3, 6, and 12 cycles/degree) for first implanted eyes in Best Case Set (BCS), at Month 6 (Visit 4)
Primary Safety Outcome
Time frame: Month 6
Rate of secondary surgical interventions related to the optical properties of the lens for first implanted eyes, through 6 months.
Primary Safety Outcome
Time frame: Month 6
Rate of Posterior Chamber IOL cumulative and persistent adverse events (AEs) listed in the ISO 11979-7:2024 Table E.2, for first implanted eyes, through 6 months.
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 13 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Cataract Senile
Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Masked, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of ZOC2017217 in Subjects With Age-Related Cataract
Age Related Cataracts
Active, not recruitingObservational study
Multicenter Study on the Use of Intraoperative OCT in the Diagnosis and Management of Lens Diseases
Lens Diseases, Cataract
Active, not recruiting
A Clinical Feasibility Study of the Aquea Intracanalicular Glaucoma Micro-coil Stent
Glaucoma, Open-Angle, Cataract Senile
RecruitingObservational study
Small RNA tRF-31 Changes in Patients With Age-Related Cataract
Cataract
RecruitingObservational study
The Impact of Surgical Procedures on Postoperative Outcomes in Cataract Phacoemulsification and Analysis of Related Factors
Age-related Cataract
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.
Seth M Pantanelli, MD principal investigator
Penn State Health
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract Surgery in people with Cataract Senile, run by Carl Zeiss Meditec, Inc. at 14 sites 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 9 inclusion and 25 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Primary Effectiveness Outcome (time frame: Month 6). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2026.