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Papers in this Session
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Visual Outcomes, Quality of Vision, and Patient-Reported Outcomes: Trifocal Intraocular Lens Vs. Extended Depth of Focus Intraocular Lens.
Authors
Dan B. Tran, MD
Ashley T. Owyang, OD
Richard Potvin, OD
Jin H. Hwang
Purpose
To evaluate patients’ visual acuity, spectacle independence, quality of vision, and contrast sensitivity, comparing results from bilateral implantation of AcrySof® IQ PanOptix® trifocal intraocular lens and bilateral implantation of Tecnis Symfony® extended depth of focus intraocular lens.
Methods
This was a prospective, non-interventional, masked, two-arm comparative study of outcomes following successful, uncomplicated bilateral cataract surgery or refractive lens exchange surgery. Subjects were assessed during a single visit, 3 to 9 months after surgery. Visual acuity measures included the uncorrected and best distance-corrected binocular near, intermediate, and distance visual acuity (measured at 40cm, 60cm, and 4-6m respectively), with the distance-corrected near visual acuity of most interest. Other measures included a spectacle independence questionnaire, a quality of vision questionnaire, and best-corrected binocular distance contrast sensitivity (mesopic and photopic).
Results
Nineteen EDOF and 13 trifocal subjects have been evaluated to date, matched for age, and sex. Spherical equivalent refraction (p = 0.28) and refractive cylinder (p = 0.92) were not significantly different between groups. The EDOF group had a mean distance corrected VA better than the trifocal group (p < 0.01) but both were better than 20/20. The trifocal had a distance-corrected intermediate VA one line better and a near VA 2 lines better than the EDOF group (p < 0.01 for both). The reported need for spectacles at near was higher in the EDOF group (p = 0.02). Contrast sensitivity at all measured frequencies was similar between IOLs in photopic (p = 0.11) and mesopic (p = 0.05) conditions.
Conclusion
Similar refractive results were observed between the IOL groups. They had similar contrast sensitivity, suggesting comparable visual quality. The major difference was the better distance VA with the EDOF lens and the better near and intermediate VA with the trifocal lens, with the trifocal group reporting a much lower need for spectacles at near.
Dan B. Tran, MD
Ashley T. Owyang, OD
Richard Potvin, OD
Jin H. Hwang
Purpose
To evaluate patients’ visual acuity, spectacle independence, quality of vision, and contrast sensitivity, comparing results from bilateral implantation of AcrySof® IQ PanOptix® trifocal intraocular lens and bilateral implantation of Tecnis Symfony® extended depth of focus intraocular lens.
Methods
This was a prospective, non-interventional, masked, two-arm comparative study of outcomes following successful, uncomplicated bilateral cataract surgery or refractive lens exchange surgery. Subjects were assessed during a single visit, 3 to 9 months after surgery. Visual acuity measures included the uncorrected and best distance-corrected binocular near, intermediate, and distance visual acuity (measured at 40cm, 60cm, and 4-6m respectively), with the distance-corrected near visual acuity of most interest. Other measures included a spectacle independence questionnaire, a quality of vision questionnaire, and best-corrected binocular distance contrast sensitivity (mesopic and photopic).
Results
Nineteen EDOF and 13 trifocal subjects have been evaluated to date, matched for age, and sex. Spherical equivalent refraction (p = 0.28) and refractive cylinder (p = 0.92) were not significantly different between groups. The EDOF group had a mean distance corrected VA better than the trifocal group (p < 0.01) but both were better than 20/20. The trifocal had a distance-corrected intermediate VA one line better and a near VA 2 lines better than the EDOF group (p < 0.01 for both). The reported need for spectacles at near was higher in the EDOF group (p = 0.02). Contrast sensitivity at all measured frequencies was similar between IOLs in photopic (p = 0.11) and mesopic (p = 0.05) conditions.
Conclusion
Similar refractive results were observed between the IOL groups. They had similar contrast sensitivity, suggesting comparable visual quality. The major difference was the better distance VA with the EDOF lens and the better near and intermediate VA with the trifocal lens, with the trifocal group reporting a much lower need for spectacles at near.
Variability Effect on Computerized Perimetry Examination after Trifocal and Extended Depth of Focus Lenses Implantation
Authors
Maíra G. B. da Silva, MD
Thiago N. Alves, MD
Pedro C. Carricondo, MD, PhD
Antonio Motta, MD
Jonathan C. Lake, MD, PhD
Patrick F. Tzelikis, MD
Andre Lins Medeiros, MD
Mario Augusto Pereira Dias Chaves Sr., MD
Abraão F. Kós, MD, MSc
Gustavo A. Coelho, MD
Cesar Martins Cortez Vilar, MD
Takashi W. Hida, MD, PhD
Purpose
To evaluate the variability of computerized perimetry in patients submitted to phacoemulsification with implantation of trifocal or extended depth of focus intraocular lenses.
Methods
Prospective study including 45 eyes from 27 patients that underwent phacoemulsification with trifocal or extended depth of focus intraocular lens implantation. All included patients were evaluated with computerized perimetry before and 30 days after surgery. Measured outcomes were test duration (in seconds), false positive index, false negatives, foveal threshold (dB), visual field index (VFI), mean deviation (MD), and pattern standard deviation (PSD).
Results
TBD
Conclusion
TBD
Maíra G. B. da Silva, MD
Thiago N. Alves, MD
Pedro C. Carricondo, MD, PhD
Antonio Motta, MD
Jonathan C. Lake, MD, PhD
Patrick F. Tzelikis, MD
Andre Lins Medeiros, MD
Mario Augusto Pereira Dias Chaves Sr., MD
Abraão F. Kós, MD, MSc
Gustavo A. Coelho, MD
Cesar Martins Cortez Vilar, MD
Takashi W. Hida, MD, PhD
Purpose
To evaluate the variability of computerized perimetry in patients submitted to phacoemulsification with implantation of trifocal or extended depth of focus intraocular lenses.
Methods
Prospective study including 45 eyes from 27 patients that underwent phacoemulsification with trifocal or extended depth of focus intraocular lens implantation. All included patients were evaluated with computerized perimetry before and 30 days after surgery. Measured outcomes were test duration (in seconds), false positive index, false negatives, foveal threshold (dB), visual field index (VFI), mean deviation (MD), and pattern standard deviation (PSD).
Results
TBD
Conclusion
TBD
Evaluation of Refractive and Visual Outcomes with Bilateral Implantation of a Toric Multifocal Intraocular Lens Using a Blended Approach
Authors
Clayton G. Blehm, MD, ABO
Richard Potvin, OD
Purpose
To assess the refraction, visual acuity (VA) and and quality of vision of patients receiving the AcrySof® ReSTOR® Toric intraocular lens (IOL) after uneventful cataract surgery. Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye.
Methods
This study was a prospective, single-center, unmasked clinical trial to evaluate VA and rotational stability of the Toric ReSTOR IOL 3 months after cataract surgery. Patients were bilaterally implanted using a blended approach. Toric IOL calculations were completed with the Alcon Toric calculator, including the Barrett adjustment for posterior corneal astigmatism. Residual refractive astigmatism was the result of primary interest. Monocular and binocular uncorrected and best distance-corrected distance, intermediate (60cm) and near (40cm) VA were measured, along with the binocular defocus curve. Toric IOL orientation was also measured. A quality of vision questionnaire was also administered.
Results
29 subjects were enrolled. There were no statistically significant differences in between-eye keratometry, corneal astigmatism or IOL power. Subjects reported preferring vision without correction in more than half of eyes tested (32/58, 55%). Residual refractive astigmatism was ≤ 0.50 D in all eyes. Seventy-five percent of subjects (22/29) had 0.10 logMAR (20/25 Snellen) binocular uncorrected VA at all tested distances. Most subjects (22/29, 76%) reported not being bothered by any visual disturbances; glare and haloes were the most common issues. In 97% of eyes (56/58) the measured change in IOL orientation between 1 and 3 months was less than 5 degrees, with no change more than 14 degrees.
Conclusion
This blended bifocal IOL modality, with both eyes corrected for distance but different near add powers, appears to be well-tolerated by subjects with a good range of vision and minimal bother from visual disturbances. The toric IOL provided excellent astigmatism correction in this group of patients.
Clayton G. Blehm, MD, ABO
Richard Potvin, OD
Purpose
To assess the refraction, visual acuity (VA) and and quality of vision of patients receiving the AcrySof® ReSTOR® Toric intraocular lens (IOL) after uneventful cataract surgery. Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye.
Methods
This study was a prospective, single-center, unmasked clinical trial to evaluate VA and rotational stability of the Toric ReSTOR IOL 3 months after cataract surgery. Patients were bilaterally implanted using a blended approach. Toric IOL calculations were completed with the Alcon Toric calculator, including the Barrett adjustment for posterior corneal astigmatism. Residual refractive astigmatism was the result of primary interest. Monocular and binocular uncorrected and best distance-corrected distance, intermediate (60cm) and near (40cm) VA were measured, along with the binocular defocus curve. Toric IOL orientation was also measured. A quality of vision questionnaire was also administered.
Results
29 subjects were enrolled. There were no statistically significant differences in between-eye keratometry, corneal astigmatism or IOL power. Subjects reported preferring vision without correction in more than half of eyes tested (32/58, 55%). Residual refractive astigmatism was ≤ 0.50 D in all eyes. Seventy-five percent of subjects (22/29) had 0.10 logMAR (20/25 Snellen) binocular uncorrected VA at all tested distances. Most subjects (22/29, 76%) reported not being bothered by any visual disturbances; glare and haloes were the most common issues. In 97% of eyes (56/58) the measured change in IOL orientation between 1 and 3 months was less than 5 degrees, with no change more than 14 degrees.
Conclusion
This blended bifocal IOL modality, with both eyes corrected for distance but different near add powers, appears to be well-tolerated by subjects with a good range of vision and minimal bother from visual disturbances. The toric IOL provided excellent astigmatism correction in this group of patients.
Comparison between Bilateral Implantation of a Trifocal & Blended Implantation of Edof IOLs with a Diffractive Trifocal Intraocular Lens
Authors
Bharti Kashyap, MS
Birendra Prasad Kashyap, MS
Nidhi Gadkar, MS, DNB
Purpose
To compare the visual outcomes, contrast sensitivity, and patient satisfaction between bilateral implantation of a diffractive trifocal intraocular lens (IOL), and blended implantation of an extended depth of focus (EDOF) lens in dominant eye and diffractive trifocal IOL in the nondominant eye
Methods
This study assessed 40 patients (80 eyes) who had bilateral cataract surgery performed using the bilateral implantation of diffractive trifocal IOL, PANOPTIX (group 1) and blended implantation of an EDOF lens, LARA 829MP in dominant eye and diffractive trifocal IOL, PANOPTIX trifocal in the Non-dominant eye (group 2). Uncorrected distance visual acuity (UDVA) at 6m, uncorrected intermediate visual acuity (UIVA) at 80 cm and 60cm and uncorrected near visual acuity (UNVA) at 40 cm; binocular photopic & mesopic contrast sensitivity (CS), defocus curve, and responses to a patient questionnaire were evaluated
Results
UDVA Mean±SD 0.097±0.11,0.080±0.06 for Gr-1&Gr-2,P=0.56,95%CI -0.04344,0.07844),UIVA 80cm Gr-1&Gr-2 0.55±0.04 &0.25±0.04,P=0.00,95%CI=0.2684,0.3265 UIVA 60cm 0.080±0.06,0.080±0.06 for Gr-1&Gr-2 non Sig P=1.00,95%CI=-0.394,0.03941)UNVA Gr-1&Gr-2 0.05±0.06,0.08±0.07,P=0.10,95%CI=-0.0662,0.0062)Photpic without glare CS Sig better at Gr-2 6CPD(P=0.00,95%CI=-0.1765,-0.1384)12CPD P=0.00 95%CI=0.2292,0.2667)18CPD(p=0.00,95%CI=-0.4180,-0.3819)With glare Photpic CS Gr-2 Sig Better at 6cpd(p=0.00 95%CI=-0.2167,-0.1912)12cpd(p=0.00 95%CI=-0.268,-0.231),Mesopic without glare CS sig better at 6cpd (P=0.00 95%CI=0.2322,0.273),12cpd P=0.00 95%CI= -0.3157,-0.2352)for Gr-2,Defocus curve sig better-1.25D-Gr-2
Conclusion
Gr-2 Blended EDOF & TRIFOCAL implantation had better range of focus,especially beyond 60cm & exhibited Sig better CS at lower frequencies under Photopic and Mesopic conditions and less adverse visual phenomena leading to convenience in car driving ,day today activities in dim light conditions esp at intermediate distance actitives beyond 60cms
Bharti Kashyap, MS
Birendra Prasad Kashyap, MS
Nidhi Gadkar, MS, DNB
Purpose
To compare the visual outcomes, contrast sensitivity, and patient satisfaction between bilateral implantation of a diffractive trifocal intraocular lens (IOL), and blended implantation of an extended depth of focus (EDOF) lens in dominant eye and diffractive trifocal IOL in the nondominant eye
Methods
This study assessed 40 patients (80 eyes) who had bilateral cataract surgery performed using the bilateral implantation of diffractive trifocal IOL, PANOPTIX (group 1) and blended implantation of an EDOF lens, LARA 829MP in dominant eye and diffractive trifocal IOL, PANOPTIX trifocal in the Non-dominant eye (group 2). Uncorrected distance visual acuity (UDVA) at 6m, uncorrected intermediate visual acuity (UIVA) at 80 cm and 60cm and uncorrected near visual acuity (UNVA) at 40 cm; binocular photopic & mesopic contrast sensitivity (CS), defocus curve, and responses to a patient questionnaire were evaluated
Results
UDVA Mean±SD 0.097±0.11,0.080±0.06 for Gr-1&Gr-2,P=0.56,95%CI -0.04344,0.07844),UIVA 80cm Gr-1&Gr-2 0.55±0.04 &0.25±0.04,P=0.00,95%CI=0.2684,0.3265 UIVA 60cm 0.080±0.06,0.080±0.06 for Gr-1&Gr-2 non Sig P=1.00,95%CI=-0.394,0.03941)UNVA Gr-1&Gr-2 0.05±0.06,0.08±0.07,P=0.10,95%CI=-0.0662,0.0062)Photpic without glare CS Sig better at Gr-2 6CPD(P=0.00,95%CI=-0.1765,-0.1384)12CPD P=0.00 95%CI=0.2292,0.2667)18CPD(p=0.00,95%CI=-0.4180,-0.3819)With glare Photpic CS Gr-2 Sig Better at 6cpd(p=0.00 95%CI=-0.2167,-0.1912)12cpd(p=0.00 95%CI=-0.268,-0.231),Mesopic without glare CS sig better at 6cpd (P=0.00 95%CI=0.2322,0.273),12cpd P=0.00 95%CI= -0.3157,-0.2352)for Gr-2,Defocus curve sig better-1.25D-Gr-2
Conclusion
Gr-2 Blended EDOF & TRIFOCAL implantation had better range of focus,especially beyond 60cm & exhibited Sig better CS at lower frequencies under Photopic and Mesopic conditions and less adverse visual phenomena leading to convenience in car driving ,day today activities in dim light conditions esp at intermediate distance actitives beyond 60cms
Objective and Subjective Assessment of Vision Quality of a New Trifocal IOL
Authors
Jeffrey Horn, MD
Satish S. Modi, FRCS, MD
Purpose
To evaluate the best-corrected (BC), distance low contrast sensitivity (CS), VA & subjective photic phenomena after bilateral implantation with the AcrySof IQ PanOptix Trifocal Intraocular Lens (IOL) Model TFNT00 (T) compared to bilateral implantation of the AcrySof Monofocal IOL Model SN60AT (S).
Methods
Prospective, non-randomized, vision assessor-masked, multicenter (twelve sites in the USA), parallel-group study. Binocular distance CS was performed in 129 (T) and 114 (S) subjects using a backlit sine wave grating chart system (CSV1000, VectorVision) at 6 months post-op under 4 conditions: photopic (~85 cd/m2) with & without glare; mesopic (approximately 3 cd/m2) with & without glare. Binocular low contrast VA was evaluated using a 10% low contrast VA chart. Photopic testing was completed at 4 m, 66 cm, and 40 cm and under mesopic conditions at 4 m. A validated Patient Reported Outcomes questionnaire used to assess visual disturbances.
Results
Photopic CS was similar between groups in photopic conditions at 3, 6, 12 and 18 CPD with or without glare. Mesopic CS at 3, 6 and 12 CPD was lower to the photopic conditions in both groups. Low contrast VA reduced the percentage of subjects achieving 0.3 logMAR or better compared to high contrast VA for both groups. Differences in distance CS VA were not clinically significant (within 1 line).The % of subjects with binocular mesopic low contrast BCVA ≥20/40-2 was @ 40cm 93.7% (T) and 10.8% (S). Starbursts & halos were perceived in the group T (66% & 74%); however, the majority of subjects reported these symptoms as “not bothered at all” to “bothered somewhat” (88% & 89%, respectively).
Conclusion
Mean CS values for TNFT00 were within the normal range for the population. There was no clinically significant difference in CS between the groups, comparing all spatial frequencies, regardless of lighting condition or the presence of glare source. <5% subjects with the TNFT00 IOL reported starbursts & halos as “bothered very much” at Month 6.
Jeffrey Horn, MD
Satish S. Modi, FRCS, MD
Purpose
To evaluate the best-corrected (BC), distance low contrast sensitivity (CS), VA & subjective photic phenomena after bilateral implantation with the AcrySof IQ PanOptix Trifocal Intraocular Lens (IOL) Model TFNT00 (T) compared to bilateral implantation of the AcrySof Monofocal IOL Model SN60AT (S).
Methods
Prospective, non-randomized, vision assessor-masked, multicenter (twelve sites in the USA), parallel-group study. Binocular distance CS was performed in 129 (T) and 114 (S) subjects using a backlit sine wave grating chart system (CSV1000, VectorVision) at 6 months post-op under 4 conditions: photopic (~85 cd/m2) with & without glare; mesopic (approximately 3 cd/m2) with & without glare. Binocular low contrast VA was evaluated using a 10% low contrast VA chart. Photopic testing was completed at 4 m, 66 cm, and 40 cm and under mesopic conditions at 4 m. A validated Patient Reported Outcomes questionnaire used to assess visual disturbances.
Results
Photopic CS was similar between groups in photopic conditions at 3, 6, 12 and 18 CPD with or without glare. Mesopic CS at 3, 6 and 12 CPD was lower to the photopic conditions in both groups. Low contrast VA reduced the percentage of subjects achieving 0.3 logMAR or better compared to high contrast VA for both groups. Differences in distance CS VA were not clinically significant (within 1 line).The % of subjects with binocular mesopic low contrast BCVA ≥20/40-2 was @ 40cm 93.7% (T) and 10.8% (S). Starbursts & halos were perceived in the group T (66% & 74%); however, the majority of subjects reported these symptoms as “not bothered at all” to “bothered somewhat” (88% & 89%, respectively).
Conclusion
Mean CS values for TNFT00 were within the normal range for the population. There was no clinically significant difference in CS between the groups, comparing all spatial frequencies, regardless of lighting condition or the presence of glare source. <5% subjects with the TNFT00 IOL reported starbursts & halos as “bothered very much” at Month 6.
Randomized Prospective Assessment of Efficacy and Safety of a New Trifocal IOL
Authors
Robert J. Cionni, MD
W. Andrew Maxwell, MD, PhD
Satish S. Modi, FRCS, MD
Purpose
To evaluate the effectiveness of AcrySof IQ PanOptix Trifocal Intraocular Lens (IOL) Model TFNT00 when compared to the AcrySof Monofocal IOL Model SN60AT to support a PMA submission for the AcrySof IQ PanOptix Trifocal IOL.
Methods
Prospective, non-randomized, vision assessor-masked, multicenter (twelve sites in the USA), parallel-group study. Monocular VA at 40cm, 66cm and distance (4m) were measured for up to 6-months post-operatively. Safety was assessed through secondary surgical interventions (SSIs) cumulative & persistent adverse event (AE) rates, and serious AEs (SAE) were compared to ISO 11979-7:2014 safety and SPE grid rates for posterior chamber IOLs.
Results
A total of 243 subjects implanted in at least 1 eye and 241 (127 in the TFNT00 group and 114 in the SN60AT group) completed the study. Mean age was 67.3 years and 67.5% females. TFNT00 was superior to SN60AT for DCVA at 40cm [LSMeans difference of ~4 lines (0.42 logMAR)] and DCVA at 66cm [LSMeans difference of ~2 lines (0.26 logMAR)]. TFNT00 was also non-inferior for CDVA at 4 m [95% UCL of the difference of LSMeans (0.02 logMAR)]. Starbursts, halos, and glare were rated as the most bothersome symptoms in the TFNT00 group; however, <5% of subjects rated these symptoms as “bothered very much”. The rate of SSIs for TFNT00 was below the SPE threshold as set forth by ISO 11979-7.
Conclusion
The TFNT00 IOL provided better vision at 40cm and 66cm and similar vision at 4m compared with SN60AT. TFNT00 IOL is safe and effective when used as intended and according to the instructions for use and it is expected to offer the benefit of increased freedom from the need for eyeglasses or contact lenses, at a range of near to distance vision.
Robert J. Cionni, MD
W. Andrew Maxwell, MD, PhD
Satish S. Modi, FRCS, MD
Purpose
To evaluate the effectiveness of AcrySof IQ PanOptix Trifocal Intraocular Lens (IOL) Model TFNT00 when compared to the AcrySof Monofocal IOL Model SN60AT to support a PMA submission for the AcrySof IQ PanOptix Trifocal IOL.
Methods
Prospective, non-randomized, vision assessor-masked, multicenter (twelve sites in the USA), parallel-group study. Monocular VA at 40cm, 66cm and distance (4m) were measured for up to 6-months post-operatively. Safety was assessed through secondary surgical interventions (SSIs) cumulative & persistent adverse event (AE) rates, and serious AEs (SAE) were compared to ISO 11979-7:2014 safety and SPE grid rates for posterior chamber IOLs.
Results
A total of 243 subjects implanted in at least 1 eye and 241 (127 in the TFNT00 group and 114 in the SN60AT group) completed the study. Mean age was 67.3 years and 67.5% females. TFNT00 was superior to SN60AT for DCVA at 40cm [LSMeans difference of ~4 lines (0.42 logMAR)] and DCVA at 66cm [LSMeans difference of ~2 lines (0.26 logMAR)]. TFNT00 was also non-inferior for CDVA at 4 m [95% UCL of the difference of LSMeans (0.02 logMAR)]. Starbursts, halos, and glare were rated as the most bothersome symptoms in the TFNT00 group; however, <5% of subjects rated these symptoms as “bothered very much”. The rate of SSIs for TFNT00 was below the SPE threshold as set forth by ISO 11979-7.
Conclusion
The TFNT00 IOL provided better vision at 40cm and 66cm and similar vision at 4m compared with SN60AT. TFNT00 IOL is safe and effective when used as intended and according to the instructions for use and it is expected to offer the benefit of increased freedom from the need for eyeglasses or contact lenses, at a range of near to distance vision.