The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT05604781
Previous Study | Return to List | Next Study

Symfony/Synergy IOL Combination Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05604781
Recruitment Status : Completed
First Posted : November 3, 2022
Results First Posted : March 18, 2024
Last Update Posted : March 18, 2024
Sponsor:
Collaborator:
Science in Vision
Information provided by (Responsible Party):
Center For Sight

Brief Summary:
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.

Condition or disease Intervention/treatment
Bilateral Cataract Presbyopia Device: Symfony & Synergy IOL combination

Layout table for study information
Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating A Novel Strategy: The Synergy IOL Mixed and Matched With the Symfony With Intelilight
Actual Study Start Date : October 17, 2022
Actual Primary Completion Date : May 16, 2023
Actual Study Completion Date : May 16, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Group/Cohort Intervention/treatment
Symfony & Synergy IOL combination Device: Symfony & Synergy IOL combination
The Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye.




Primary Outcome Measures :
  1. Binocular Defocus Curve [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Patient Satisfaction Questionnaire [ Time Frame: 3 months ]
    Percentage for participants who are completely or mostly satisfied with their overall vision will be assessed

  2. Spectacle Independence for Near Activities Questionnaire [ Time Frame: 3 months ]
    Percentage of participants reporting the need to wear glasses all the time for near activities will be assessed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from two ophthalmology clinics.
Criteria

Inclusion Criteria:

  1. Subject is undergoing bilateral lens extraction with intraocular lens implantation of the Symfony with InteliLight in the dominant eye and a Synergy in the non-dominant eye.
  2. Gender: Males and Females.
  3. Age: 50 years and older.
  4. Willing and able to provide written informed consent for participation in the study
  5. Willing and able to comply with scheduled visits and other study procedures.
  6. Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 2 to 30 days between surgeries
  7. Subjects who require an IOL power in the range of +5.00 D to +34.0 D only.
  8. Subjects who require a toric IOL up to +3.75 D at the IOL plane (2.57 D corneal plane).
  9. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion Criteria:

  1. Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
  2. Uncontrolled diabetes.
  3. Use of any systemic or topical drug known to interfere with visual performance.
  4. Contact lens use during the active treatment portion of the trial.
  5. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
  6. Clinically significant corneal dystrophy
  7. History of chronic intraocular inflammation.
  8. History of retinal detachment.
  9. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
  10. Previous intraocular surgery.
  11. Previous corneal refractive surgery (i.e. LASIK, photorefractive keratectomy, radial keratotomy).
  12. Previous keratoplasty
  13. Severe dry eye
  14. Pupil abnormalities
  15. Anesthesia other than topical or peribulbar anesthesia (i.e. retrobulbar, general, etc).
  16. Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
  17. Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05604781


Locations
Layout table for location information
United States, Florida
Center For Sight
Venice, Florida, United States, 34285
United States, South Carolina
Helga Sandoval
Mount Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
Center For Sight
Science in Vision
  Study Documents (Full-Text)

Documents provided by Center For Sight:
Layout table for additonal information
Responsible Party: Center For Sight
ClinicalTrials.gov Identifier: NCT05604781    
Other Study ID Numbers: CFS-22-001
First Posted: November 3, 2022    Key Record Dates
Results First Posted: March 18, 2024
Last Update Posted: March 18, 2024
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors