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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AcrySof® IQ PanOptix® (Alcon Laboratories, Inc., Fort Worth, TX) | Experimental | The subject will be implanted bilaterally during cataract surgery |
|
| Synergy® (Johnson & Johnson Surgical Vision, Santa Ana, CA) | Experimental | The subject will be implanted bilaterally during cataract surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular DCNVA | Binocular DCNVA of Trifocal (Alcon Panoptix) versus EDOF/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm | Up to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Disturbances Evaluation | Patient reported occurrences of visual disturbances of each group (unsolicited) at all visits | at all visits |
| Visual Disturbances Evaluation by Questionnaire (QUVID) |
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Inclusion Criteria:
Note: Ocular criteria must be met in both eyes.
Exclusion Criteria:
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Satish S Modi, MD | Contact | 845-454-1025 | smodieyes@aol.com | |
| Sarah O Piza | Contact | 845-454-1025 | sortiz523@aol.com |
| Name | Affiliation | Role |
|---|---|---|
| Satish S Modi, MD | Seeta Eye Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Care Now | Recruiting | Panama City | Florida | 32405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40277405 | Derived | 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. |
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| 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 Surgery | Procedure | IOL implantation will be performed |
|
Patient reported visual disturbances by questionnaire (QUVID) postop
| Up to Month 6 |
| BCDVA and DCIVA (60 cm) | Monocular and binocular BCDVA and DCIVA (60 cm) in both groups will be measured | Up to Month 6 |
| DCNVA (40 cm) | Monocular DCNVA (40 cm) in both groups will be measured | Up to Month 6 |
| Uncorrected Monocular and Binocular VA | Uncorrected monocular and binocular VA at distance, intermediate (60 cm) and near (40 cm) | Up to Month 6 |
| Visual Disturbances Evaluation by Questionnaire (IOL SAT) | Patient satisfaction of each group by questionnaire (IOL SAT) postop | 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) | Up to Month 6 |
| Seeta Eye Center | Recruiting | Poughkeepsie | New York | 12603 | United States |
|
| Eye Care Specialists | Recruiting | Kingston | Pennsylvania | 18704 | United States |
|
| Lehmann Eye Center | Recruiting | Nacogdoches | Texas | 75965 | United States |
|
| Northwest Eye Surgeons | Recruiting | Seattle | Washington | 98125 | United States |
|
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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