CataractNCT05186298
Prospective Evaluation and Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants
A study testing AcrySof® IQ PanOptix®, Synergy® and Cataract Surgery in people with Cataract, run by Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons at 5 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- AcrySof® IQ PanOptix®, Synergy® and Cataract Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 5 sitesUnited States
- Study dates
- 2 Nov 2021to May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Note: Ocular criteria must be met in both eyes.
- are willing and able to understand and sign an informed consent;
- are willing and able to attend all study visits;
- Subjects diagnosed with bilateral cataracts with planned cataract removal by femto assisted phacoemulsification with a clear corneal incision and intraoperative aberrometry assisted
- Clear intraocular media other than cataracts.
- Projected BCDVA of better than 0.10 logMAR.
- Preoperative regular keratometric astigmatism (by biometer) of less than or equal to 0.75D, in both eyes
- Biometer IOL calculations within +6.0 - +30.0 power range
Who cannot join
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Clinically significant corneal abnormality, irregularity, inflammation, or edema aberrations, corneal disease, degeneration, or conditions affecting postoperative visual acuity
- Glaucoma or Ocular Hypertension
- Planned multiple procedures (eg MIGS)
- Amblyopia, Strabismus
- Patient's IOL calculation that are outside the range of available lenses
Show all 13Show fewer
- Prior corneal refractive surgery or other corneal surgery (e.g., corneal transplant, lamellar keratoplasty, LASIK, PRK)
- Previous anterior or posterior chamber surgery (e.g., vitrectomy) that the investigator feels may compromise visual outcomes
- Diabetic retinopathy if the investigator feels this will compromise visual outcomes
- Macular Pathology (i.e., ERM, ARMD, DMR etc.) if the investigator feels this will compromise visual outcomes
- History of retinal detachment
- If, in the surgeon's opinion, the subject is not an appropriate candidate for multifocal IOL implantation (eg. patients who are professional night drivers or pilots, and those with other occupations for whom induces dysphotopsias could put their career at risk)
- Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect post-operative visual acuity.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Eye Care Specialists
Kingston, Pennsylvania, 18704
Richard Roth, D.O., patti.myers@vipeyes.com
Richard Roth, D.O.
- Recruiting
Lehmann Eye Center
Nacogdoches, Texas, 75965
Robert Lehmann, M.D., olucas@lehmanneyecenter.com
Robert Lehmann, M.D.
- Recruiting
Eye Care Now
Panama City, Florida, 32405
Bret Fisher, M.D., cmenck@eyecarenow.com
Bret Fisher, M.D.
- Recruiting
Seeta Eye Center
Poughkeepsie, New York, 12603
Satish S Modi, MD, spiza@seetaeye.com
Satish S Modi, MD
- Recruiting
Northwest Eye Surgeons
Seattle, Washington, 98125
Audrey T Rostov, M.D., hannah.seo@nweyes.com
Audrey T Rostov, M.D.
About this study
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.
Read the detailed description
Eligible test subjects will be patients diagnosed with cataracts bilaterally who are interested and eligible for implantation of a presbyopia-correcting multifocal intraocular lenses.
Subjects will participate in ten study visits. Visits will include a screening visit (both eyes evaluated), one operative visit for each eye, and 7 postoperative visits. Both eyes will be implanted, with the second eye surgery occurring X (depends on the patient and the schedule) days after the first.
- Conditions
- Cataract
- Being tested
- AcrySof® IQ PanOptix®, Synergy®, 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.
AcrySof® IQ PanOptix®Device
The AcrySof IQ PanOptix® (Alcon) mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL
Synergy®Device
The TECNIS Synergy™ IOLs mitigate the effects of presbyopia by providing far vision comparable to an aspheric monofocal IOL. Compared to an aspheric monofocal IOL, the lens provides significantly improved intermediate and near vision, including in low-light conditions.
Cataract SurgeryProcedure or surgery
IOL implantation will be performed
| Study group | Role | What they receive |
|---|---|---|
| AcrySof® IQ PanOptix® (Alcon Laboratories, Inc., Fort Worth, TX) | Experimental | The subject will be implanted bilaterally during cataract surgery Receives: Device: AcrySof® IQ PanOptix®; Procedure: Cataract Surgery |
| Synergy® (Johnson & Johnson Surgical Vision, Santa Ana, CA) | Experimental | The subject will be implanted bilaterally during cataract surgery Receives: Device: Synergy®; Procedure: Cataract Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular DCNVA
Binocular DCNVA of Trifocal (Alcon Panoptix) versus EDOF/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm
Measured: Up to Month 6
Secondary outcomes (7)
Visual Disturbances Evaluation
Patient reported occurrences of visual disturbances of each group (unsolicited) at all visits
Measured: at all visits
Visual Disturbances Evaluation by Questionnaire (QUVID)
Patient reported visual disturbances by questionnaire (QUVID) postop
Measured: Up to Month 6
BCDVA and DCIVA (60 cm)
Monocular and binocular BCDVA and DCIVA (60 cm) in both groups will be measured
Measured: Up to Month 6
DCNVA (40 cm)
Monocular DCNVA (40 cm) in both groups will be measured
Measured: Up to Month 6
Uncorrected Monocular and Binocular VA
Uncorrected monocular and binocular VA at distance, intermediate (60 cm) and near (40 cm)
Measured: Up to Month 6
Visual Disturbances Evaluation by Questionnaire (IOL SAT)
Patient satisfaction of each group by questionnaire (IOL SAT) postop
Measured: Up to Month 6
Defocus Curve
Defocus curve tested in binocular photopic conditions (+1.00 to -3.00 in 0.50D except +0.50 to -0.50 in 0.25D)
Measured: Up to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start2 Nov 2021
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies 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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Satish S Modi, MD, Principal investigator, Seeta Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186298
- Sponsor's protocol ID
- 68985013
- Status last verified
- Jan 2022
- First submitted
- 16 Nov 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Modi SS, Lehmann RP, Fisher BL, Roth RE, Reiser H. Comparison of visual function and patient-reported outcomes between two full range of field intraocular lenses: a randomized controlled study. J Cataract Refract Surg. 2025 Aug 1;51(8):695-702. doi: 10.1097/j.jcrs.0000000000001678.
PubMed 40277405
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation and Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants
- ClinicalTrials.gov ID
- NCT05186298
- Acronym / sponsor ID
- 68985013
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Alterman, Modi, & Wolter Ophthalmic Physicians & SurgeonsUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 11 Jan 2022 (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 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.
Detailed description
Eligible test subjects will be patients diagnosed with cataracts bilaterally who are interested and eligible for implantation of a presbyopia-correcting multifocal intraocular lenses.
Subjects will participate in ten study visits. Visits will include a screening visit (both eyes evaluated), one operative visit for each eye, and 7 postoperative visits. Both eyes will be implanted, with the second eye surgery occurring X (depends on the patient and the schedule) days after the first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AcrySof® IQ PanOptix® (Alcon Laboratories, Inc., Fort Worth, TX) | Experimental | Device: AcrySof® IQ PanOptix®, Procedure: Cataract SurgeryThe subject will be implanted bilaterally during cataract surgery |
| Synergy® (Johnson & Johnson Surgical Vision, Santa Ana, CA) | Experimental | Device: Synergy®, Procedure: Cataract SurgeryThe subject will be implanted bilaterally during cataract surgery |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Note: Ocular criteria must be met in both eyes.
- are willing and able to understand and sign an informed consent;
- are willing and able to attend all study visits;
- Subjects diagnosed with bilateral cataracts with planned cataract removal by femto assisted phacoemulsification with a clear corneal incision and intraoperative aberrometry assisted
- Clear intraocular media other than cataracts.
Key exclusion criteria (13 listed)
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Clinically significant corneal abnormality, irregularity, inflammation, or edema aberrations, corneal disease, degeneration, or conditions affecting postoperative visual acuity
- Glaucoma or Ocular Hypertension
- Planned multiple procedures (eg MIGS)
- Amblyopia, Strabismus
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 |
|---|---|---|
| AcrySof® IQ PanOptix®The AcrySof IQ PanOptix® (Alcon) mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL | Device | AcrySof® IQ PanOptix® (Alcon Laboratories, Inc., Fort Worth, TX) |
| Synergy®The TECNIS Synergy™ IOLs mitigate the effects of presbyopia by providing far vision comparable to an aspheric monofocal IOL. Compared to an aspheric monofocal IOL, the lens provides significantly improved intermediate and near vision, including in low-light conditions. | Device | Synergy® (Johnson & Johnson Surgical Vision, Santa Ana, CA) |
| Cataract SurgeryIOL implantation will be performed | Procedure or surgery | AcrySof® IQ PanOptix® (Alcon Laboratories, Inc., Fort Worth, TX), Synergy® (Johnson & Johnson Surgical Vision, Santa Ana, CA) |
Primary outcome
Binocular DCNVA
Time frame: Up to Month 6
Binocular DCNVA of Trifocal (Alcon Panoptix) versus EDOF/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm
7 secondary outcomes
Visual Disturbances Evaluation
Time frame: at all visits
Visual Disturbances Evaluation by Questionnaire (QUVID)
Time frame: Up to Month 6
BCDVA and DCIVA (60 cm)
Time frame: Up to Month 6
DCNVA (40 cm)
Time frame: Up to Month 6
Uncorrected Monocular and Binocular VA
Time frame: Up to Month 6
Visual Disturbances Evaluation by Questionnaire (IOL SAT)
Time frame: Up to Month 6
Defocus Curve
Time frame: Up to Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Derived from this study: PubMed 40277405Modi SS, Lehmann RP, Fisher BL, Roth RE, Reiser H. Comparison of visual function and patient-reported outcomes between two full range of field intraocular lenses: a randomized controlled study. J Cataract Refract Surg. 2025 Aug 1;51(8):695-702. doi: 10.1097/j.jcrs.0000000000001678.
- Individual participant dataSharing planned: No
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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.
Satish S Modi, MD principal investigator
Seeta Eye Centre
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcrySof® IQ PanOptix®, Synergy® and Cataract Surgery in people with Cataract, run by Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons at 5 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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Satish S Modi, MD (845-454-1025, smodieyes@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular DCNVA (time frame: Up to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05186298, which also lists 1 linked publication.
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 11 Jan 2022.