Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT06264232
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2024-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AT ELANA 841P Posterior Chamber Intraocular Lens for Correction of Aphakia Following Cataract Removal
Sponsor:
Carl Zeiss Meditec, Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: