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Papers in this Session
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Re-Thinking Keratoconus - Use of a Novel Patient Centric Implant for Visual Correction in Non-Cross-Linked Pateints
Authors
Francis W. Price Jr., MD
Marwan Ghabra, FRCSEd
Methods
A prospective non-masked proof of concept study 2 non cross linked keratoconic patients with de-centred cones within the central cornea. Minimal corneal thickness at the central 6mm zone was 400 microns. A radial intracorneal inlay was surgically implanted in each patient in alignment with the keratoconic cone (determined by the elevation maps from corneal topography. A comprehensive ophthalmic examination was conducted along with pre-Op and subsequent follow up corneal tomography were taken Visual acuity (VA) was measured using a tumbling letter ‘E’ test at 100% contrast in white light. Centration was measured via analysis of the corneal topography image
Results
X and Y values of the highest elevation point within the cone was measured from the pentacam at each consultation and follow up. an average of 45% shifting of the X and Y values towards topographical 0 demonstrate objective re-centration of the cone. With subsequent improvement in corneal symmetry and regularity. Visual acuity demonstrated an average of over 5 lines of improvement in uncorrected visual distance acuity among this cohort.
Conclusion
Objective numerical evidence of X and Y axis centration improvement on the corneal topography coupled with improvement in UDVA and CDVA at final follow up and scleral lens independence among among 9 out 11 patients coupled with no evidence of adverse events provide a good foundation of results.
Francis W. Price Jr., MD
Marwan Ghabra, FRCSEd
Methods
A prospective non-masked proof of concept study 2 non cross linked keratoconic patients with de-centred cones within the central cornea. Minimal corneal thickness at the central 6mm zone was 400 microns. A radial intracorneal inlay was surgically implanted in each patient in alignment with the keratoconic cone (determined by the elevation maps from corneal topography. A comprehensive ophthalmic examination was conducted along with pre-Op and subsequent follow up corneal tomography were taken Visual acuity (VA) was measured using a tumbling letter ‘E’ test at 100% contrast in white light. Centration was measured via analysis of the corneal topography image
Results
X and Y values of the highest elevation point within the cone was measured from the pentacam at each consultation and follow up. an average of 45% shifting of the X and Y values towards topographical 0 demonstrate objective re-centration of the cone. With subsequent improvement in corneal symmetry and regularity. Visual acuity demonstrated an average of over 5 lines of improvement in uncorrected visual distance acuity among this cohort.
Conclusion
Objective numerical evidence of X and Y axis centration improvement on the corneal topography coupled with improvement in UDVA and CDVA at final follow up and scleral lens independence among among 9 out 11 patients coupled with no evidence of adverse events provide a good foundation of results.
Meeting High Expectations: Trans-Epithelial Photorefractive Keratectomy (TE-PRK) for Very Low Myopic and Astigmatic Corrections. (No Audio)
Authors
Mukhtar Bizrah, MBBS, FRCOphth
David TC. Lin, MD, FRCS
Simon P. Holland, MD, FRCS
Shwetabh Verma, MSc
Methods
Retrospective case series study at laser refractive clinic. Case inclusion criteria were preoperative spherical equivalent (SE) of ≥-0.50D to ≤ -1.50D with ≤1.50D cylinder. Patients were treated with TE-PRK using SA1050 SmartSurfACE, without epithelial thickness measurement with phototherapeutic keratectomy (PTK) of 55µm. Data analyzed: pre- and post-operative uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA) and spherical equivalent (SE) in eyes with sufficient data for analysis at 12 months.
Results
82 eyes met the inclusion criteria with 23 eyes underwent cataract and/or laser refractive surgery previously. Refractive improvement from pre-operative SE of -1.22±0.24D to post-operative SE +0.07±0.30D . All cases (82 eyes) achieved UDVA ≥20/40 at 12 months and 98% (80) achieved ≥20/25. 20 (24%) gained one line or more of CDVA with 4 (5%) lost 1 line or more of CDVA.
Conclusion
Patients with very low myopic and myopic astigmatic refractive error may be effectively treated with TE-PRK using Schwind Amaris 1050 excimer laser. The technique may also applicable for correction of small degrees of residual refractive errors after cataract or laser refractive surgery with high predictability.
Mukhtar Bizrah, MBBS, FRCOphth
David TC. Lin, MD, FRCS
Simon P. Holland, MD, FRCS
Shwetabh Verma, MSc
Methods
Retrospective case series study at laser refractive clinic. Case inclusion criteria were preoperative spherical equivalent (SE) of ≥-0.50D to ≤ -1.50D with ≤1.50D cylinder. Patients were treated with TE-PRK using SA1050 SmartSurfACE, without epithelial thickness measurement with phototherapeutic keratectomy (PTK) of 55µm. Data analyzed: pre- and post-operative uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA) and spherical equivalent (SE) in eyes with sufficient data for analysis at 12 months.
Results
82 eyes met the inclusion criteria with 23 eyes underwent cataract and/or laser refractive surgery previously. Refractive improvement from pre-operative SE of -1.22±0.24D to post-operative SE +0.07±0.30D . All cases (82 eyes) achieved UDVA ≥20/40 at 12 months and 98% (80) achieved ≥20/25. 20 (24%) gained one line or more of CDVA with 4 (5%) lost 1 line or more of CDVA.
Conclusion
Patients with very low myopic and myopic astigmatic refractive error may be effectively treated with TE-PRK using Schwind Amaris 1050 excimer laser. The technique may also applicable for correction of small degrees of residual refractive errors after cataract or laser refractive surgery with high predictability.
Long-Term Multicenter Retrospective Study of Implantable Collamer Lens for the Correction of Myopia in China.
Authors
Yuexi Y. Chen, BSN
Qizhi Q. Zhou, MA
Purpose
To observe the long-term clinical efficacy of implantable collamer lens (ICL) for the correction of myopia in China.
Methods
A multicenter retrospective study. A total of 320 eyes from 3 sites with complete 5-year follow up were selected from 964 eyes which underwent implantation of ICL from December 2009 to May 2014. The uncorrected distance visual acuity (UCVA), best corrected distance visual acuity (BCVA), spherical equivalent (SE), intraocular pressure, corneal endothelial count(ECD), axis length (AL), vault and anterior chamber data were analyzed for the preoperative and last postoperative visits(5.5±1.0) years (P＜0.05).
Results
At the last visit, the mean UCVA and mean BCVA were both better than pre-operation(P＜0.001). The SE was (-0.91±0.82) D (range, -4.00D to +0.38 D). The safety index was 1.10±0.20 and the effective index was 0.86±0.30. The mean vault was (402±185) um (range, 24um to 1300um). The visual quality questionnaire showed that patients were satisfied with the surgery. No serious complications occurred.
Conclusion
ICL implantation surgery is safe and effective in the long-term for correction of myopia with high satisfaction.
Yuexi Y. Chen, BSN
Qizhi Q. Zhou, MA
Purpose
To observe the long-term clinical efficacy of implantable collamer lens (ICL) for the correction of myopia in China.
Methods
A multicenter retrospective study. A total of 320 eyes from 3 sites with complete 5-year follow up were selected from 964 eyes which underwent implantation of ICL from December 2009 to May 2014. The uncorrected distance visual acuity (UCVA), best corrected distance visual acuity (BCVA), spherical equivalent (SE), intraocular pressure, corneal endothelial count(ECD), axis length (AL), vault and anterior chamber data were analyzed for the preoperative and last postoperative visits(5.5±1.0) years (P＜0.05).
Results
At the last visit, the mean UCVA and mean BCVA were both better than pre-operation(P＜0.001). The SE was (-0.91±0.82) D (range, -4.00D to +0.38 D). The safety index was 1.10±0.20 and the effective index was 0.86±0.30. The mean vault was (402±185) um (range, 24um to 1300um). The visual quality questionnaire showed that patients were satisfied with the surgery. No serious complications occurred.
Conclusion
ICL implantation surgery is safe and effective in the long-term for correction of myopia with high satisfaction.
Initial Clinical Experience with Wavefront-Guided PRK Enhancement after SMILE
Authors
Gabriel S. Valerio, MD, ABO
Edward E. Manche, MD
Methods
This study is a prospective noncomparative interventional case series of 5 eyes that underwent SMILE (Small-Incision Lenticule Extraction) followed by enhancement with Wavefront Guided PRK (Photorefractive Keratectomy). Each eye was evaluated preoperatively, postoperatively from SMILE, and postoperatively from PRK measuring uncorrected distance visual acuity, corrected distance visual acuity, refractive error and wavefront aberrometry.
Results
This case series that followed 5 eyes showed that preoperative uncorrected visual acuity averaged 1.68 LogMAR. Post-SMILE and pre-PRK uncorrected visual acuity averaged 0.30 LogMAR. Post-SMILE and pre-PRK spherical equivalent was -0.98 diopters. Post- PRK operative uncorrected vision resulted in 0.07, 0.0 LogMAR at postoperative months 6 and 12. Post-PRK mean spherical equivalents were 0.19, -0.13 at postoperative months 6 and 12. In regards to HOA, pre-SMILE averaged 0.38 RMS, pre-PRK enhancement averaged 0.52, post-PRK averaged 0.60 at postoperative month 12.The mean time to enhancement was 11.6 months. None of these findings are statistically significant in this small case series.
Conclusion
Overall, PRK enhancement after initial SMILE surgery resulted in excellent final visual acuities. Post-PRK spherical equivalent and HOA trended lower by postoperative month 12. It is unclear if HOAs will return to levels similar to those eyes without an enhancement surgery. Future studies are required for further analysis.
Gabriel S. Valerio, MD, ABO
Edward E. Manche, MD
Methods
This study is a prospective noncomparative interventional case series of 5 eyes that underwent SMILE (Small-Incision Lenticule Extraction) followed by enhancement with Wavefront Guided PRK (Photorefractive Keratectomy). Each eye was evaluated preoperatively, postoperatively from SMILE, and postoperatively from PRK measuring uncorrected distance visual acuity, corrected distance visual acuity, refractive error and wavefront aberrometry.
Results
This case series that followed 5 eyes showed that preoperative uncorrected visual acuity averaged 1.68 LogMAR. Post-SMILE and pre-PRK uncorrected visual acuity averaged 0.30 LogMAR. Post-SMILE and pre-PRK spherical equivalent was -0.98 diopters. Post- PRK operative uncorrected vision resulted in 0.07, 0.0 LogMAR at postoperative months 6 and 12. Post-PRK mean spherical equivalents were 0.19, -0.13 at postoperative months 6 and 12. In regards to HOA, pre-SMILE averaged 0.38 RMS, pre-PRK enhancement averaged 0.52, post-PRK averaged 0.60 at postoperative month 12.The mean time to enhancement was 11.6 months. None of these findings are statistically significant in this small case series.
Conclusion
Overall, PRK enhancement after initial SMILE surgery resulted in excellent final visual acuities. Post-PRK spherical equivalent and HOA trended lower by postoperative month 12. It is unclear if HOAs will return to levels similar to those eyes without an enhancement surgery. Future studies are required for further analysis.
6-Month Results of Allograft Corneal Inlays in the Treatment of Presbyopia
Author
Arthur B Cummings, MD
Purpose
To evaluate the safety and efficacy of the Allotex presbyopic corneal inlay on distance and reading vision.
Methods
45 eyes of 45 patients underwent Allotex corneal allograft presbyopic inlay implantation in the non-dominant eye to improve reading vision at the Wellington Eye Clinic in Dublin, Ireland. The 6-month results will be provided in terms of reading vision gained, unaided distance vision lost in the treated eye, unaided binocular distance vision, safety and efficacy.
Results
45 patients (N=45 eyes) were enrolled at this site. To date, 2 patients already have 12-month data and 16 have 6-month data. At the time of this presentation, all 45 patients will have 6-month data. Initial results are showing a marked improvement in uncorrected reading vision with 15 out of 16 eyes having N5 vision and 1 with N6 vision. The UDVA in the allograft eye is reduced by a mean <2 lines while the binocular vision is unaffected. There have been no adverse reactions or any signs of rejection thus far.
Conclusion
In this clinical trial thus far, the Allotex presbyopic corneal inlay has performed very well with high patient satisfaction, markedly improved reading vision and minimal impact on distance vision and an excellent safety profile.
Arthur B Cummings, MD
Purpose
To evaluate the safety and efficacy of the Allotex presbyopic corneal inlay on distance and reading vision.
Methods
45 eyes of 45 patients underwent Allotex corneal allograft presbyopic inlay implantation in the non-dominant eye to improve reading vision at the Wellington Eye Clinic in Dublin, Ireland. The 6-month results will be provided in terms of reading vision gained, unaided distance vision lost in the treated eye, unaided binocular distance vision, safety and efficacy.
Results
45 patients (N=45 eyes) were enrolled at this site. To date, 2 patients already have 12-month data and 16 have 6-month data. At the time of this presentation, all 45 patients will have 6-month data. Initial results are showing a marked improvement in uncorrected reading vision with 15 out of 16 eyes having N5 vision and 1 with N6 vision. The UDVA in the allograft eye is reduced by a mean <2 lines while the binocular vision is unaffected. There have been no adverse reactions or any signs of rejection thus far.
Conclusion
In this clinical trial thus far, the Allotex presbyopic corneal inlay has performed very well with high patient satisfaction, markedly improved reading vision and minimal impact on distance vision and an excellent safety profile.
Micro-Radial and Arcuate Incisions for the Correction of Residual Pseudophakic Refractive Errors
Author
Frank A. Bucci Jr., MD
Purpose
To evaluate the visual and refractive outcomes with the combination of micro-radial and arcuate incisions, micro-radial incisions alone, or AK incisions alone performed in pseudophakic eyes for the management of residual myopic astigmatism, mypoia alone, or astigmatism alone.
Methods
1,042 eyes having undergone micro-RK/AK (n=532), micro-RK alone(n=110), or AK alone(n=400) for the correction of residual pseudophakic refractive errors were retrospectively reviewed to evaluate the uncorrected visual and refractive outcomes. The Lindstrom “mini-RK” nomogram was used to perform 1, 2, or 4 micro-radial incisions when myopia was present (n=642) with optical zones of 5.00, 5.25, or 5.50 mm. Micro-RK incisions were never greater in length than 2.75mm. Myopia was corrected from a range of -0.25D to -1.50D and astigmatism was corrected up to 2.50D. Cases were performed between April, 1998 and January, 2020.
Results
The mean preop myopic sph equiv was -0.59D(.46) and the mean preop refractive astigmatism was 1.03D(.52). The postop mean sph equiv was reduced to -0.07D(.40) and the mean postop refractive astig was reduced to 0.24D(.47). The mean uncorrected Snellen visual acuity improved from 20/38.6 to 20/23.8. 51.7% of eyes received 2 micro-RK incisions, 21.7% received 1 incision, & 26.6% received 4 incisions. 70.2% percent of eyes had an optical zone of 5.50mm, 25.7% had an optical zone of 5.25mm, and 4.0% had an optical zone of 5.00mm. No infections or induced dry eye were observed. Daily visual fluctuations or hyperopic shifts were not observed from these relatively short micro-radial incisions.
Conclusion
1) Micro-RK/AK is a safe and effective treatment for residual myopic astigmatism in pseudophakic pts 2) No hyperopic shift or fluctuation in vision was observed 3) Micro-RK/AK leaves the central 5mm of cornea untouched, does not create a neurotrophic cornea or epithelial modulation, and provides rapid improvement in vision with minimal discomfort.
Frank A. Bucci Jr., MD
Purpose
To evaluate the visual and refractive outcomes with the combination of micro-radial and arcuate incisions, micro-radial incisions alone, or AK incisions alone performed in pseudophakic eyes for the management of residual myopic astigmatism, mypoia alone, or astigmatism alone.
Methods
1,042 eyes having undergone micro-RK/AK (n=532), micro-RK alone(n=110), or AK alone(n=400) for the correction of residual pseudophakic refractive errors were retrospectively reviewed to evaluate the uncorrected visual and refractive outcomes. The Lindstrom “mini-RK” nomogram was used to perform 1, 2, or 4 micro-radial incisions when myopia was present (n=642) with optical zones of 5.00, 5.25, or 5.50 mm. Micro-RK incisions were never greater in length than 2.75mm. Myopia was corrected from a range of -0.25D to -1.50D and astigmatism was corrected up to 2.50D. Cases were performed between April, 1998 and January, 2020.
Results
The mean preop myopic sph equiv was -0.59D(.46) and the mean preop refractive astigmatism was 1.03D(.52). The postop mean sph equiv was reduced to -0.07D(.40) and the mean postop refractive astig was reduced to 0.24D(.47). The mean uncorrected Snellen visual acuity improved from 20/38.6 to 20/23.8. 51.7% of eyes received 2 micro-RK incisions, 21.7% received 1 incision, & 26.6% received 4 incisions. 70.2% percent of eyes had an optical zone of 5.50mm, 25.7% had an optical zone of 5.25mm, and 4.0% had an optical zone of 5.00mm. No infections or induced dry eye were observed. Daily visual fluctuations or hyperopic shifts were not observed from these relatively short micro-radial incisions.
Conclusion
1) Micro-RK/AK is a safe and effective treatment for residual myopic astigmatism in pseudophakic pts 2) No hyperopic shift or fluctuation in vision was observed 3) Micro-RK/AK leaves the central 5mm of cornea untouched, does not create a neurotrophic cornea or epithelial modulation, and provides rapid improvement in vision with minimal discomfort.