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Moderator
Sam Garg, MD, ABO
Panelists
Mitchell P. Weikert, MD, MS, ABO
Rosalind Vo, MD
Viewing Papers
Expand a paper title to the right to view the paper abstract and authors, and view the full session above.
Presenting Author
Kumar J. Doctor, MD
Co-Authors
Shivani Pattnaik MS
Purpose
To present a novel speculum design that improves dye retention during corneal cross-linking procedures, aiming to enhance treatment efficacy and reduce riboflavin wastage
Methods
We tested of a new speculum design with integrated dye retention features. The modified speculum in comparison to traditional designs had the facility to retain riboflavin dye for better penetration into stroma undergoing corneal cross-linking. Parameters such as dye distribution, retention time, ease of application were analyzed.
Results
The novel speculum design demonstrated improved dye retention with more consistent corneal coverage and reduced wastage compared to traditional speculums.
Conclusion
The innovative speculum design offers a promising advancement in corneal cross-linking by improving dye retention and distribution. This modification may contribute to more effective treatments and less dye wastage and better outcomes
Presenting Author
Gil Ben-David, MD
Co-Authors
Olga Reitblat MHA, MD, Avital Adler MD, Uri Elbaz MD
Purpose
This study evaluates the effectiveness of an accelerated transepithelial (EPI-ON) crosslinking (CXL) protocol in pediatric keratoconus. It investigates whether this approach, which offers shorter operative time, effectively stabilizes KCN in children, who typically experience rapid progression and higher post-operative discomfort.
Methods
Retrospective cohort study of KCN patients at the cornea clinic of Schneider Children's Medical Center. Inclusion criteria was under 18 years, no previous CXL and follow-up over 1 year. Patients were treated with EPI-ON CXL protocol using the KXL system (Averdo, inc.). The KXL machine projected pulsed UV-A light at 45mw/cm2 for 5 minutes and 20 seconds (1 second on, 1 second off), a total dose of 7.2J/cm2, following 10 minutes of riboflavin application. Medical records were reviewed for demographic data, clinical presentation, corneal tomography parameters, and visual outcomes. The primary outcome was disease progression defined as >1D of change in K-max at the end of the follow up.
Results
Study Included 13 patients (26 eyes), 8 male and 5 female with a mean age of 15.48±1.95 years. Mean duration of follow-up was 19.82±7.8 months. During follow up, progression of >1D in K-max was noted in 13 eyes (50%) and in K-mean in 9 eyes (34.6%). Significant progression from prior to CXL to last follow-up was found in K-Central (47.25± 4.043D vs. 49.16± 4.86D, respectively, p<0.001), K-max (51.86± 4.97D vs. 53.18± 6.07D, respectively, p=0.001), K-mean (46.66± 2.94D vs. 47.54± 3.45D, respectively, p=0.001) and thinnest corneal thickness (480.88± 33.6µm vs. 475.17± 32.35µm, respectively, p=0.009). CDVA (logMAR) decreased non-significantly from 0.1±0.1 to 0.14±0.14, respectively (p=0.155).
Conclusion
Accelerated EPI-ON CXL has shown inferior efficacy compared to Epi-OFF CXL literature data in halting progression of Pediatric KCN with only half of the eyes showing topographic stability.
Presenting Author
Austin S. Yu, MD
Co-Authors
Peter Hersh MD, Steven Greenstein MD
Purpose
To report outcomes of simultaneous transepithelial topography-guided photorefractive keratectomy (TE-TGPRK) and corneal crosslinking (CXL) in patients with keratoconus (KC) and post refractive ectasia (EC).
Methods
43 eyes of 35 patients underwent simultaneous CXL (3mW/cm2) and TE-TGPRK (Contoura, Wavelight EX500, Alcon USA). CXL was performed over the ablated area with no additional manual epithelial removal. Uncorrected and best corrected visual acuity (UCVA, BCVA), manifest refraction spherical equivalent (MRSE), maximum (Kmax) and average (Kavg) keratometry, thinnest pachymetry (Pthin) and inferior superior (IS) value were measured.
Results
At 6-months, UCVA improved by -0.18±0.34 logMAR lines (LL) (p<.001) and BCVA improved -0.08±0.17LL (p=.003). MRSE changed from -1.92±3.24D to -2.19±2.28D (p=.48). Kmax flattened 5.0±3.0D (p<.001) and Kavg flattened 1.5±1.2D (p<.001). Pthin decreased from 465.8±32.9 to 426.2±47.1 (p<.001). IS value improved from 10.7±3.7D to 7.4±3.8D (p<.001).
Conclusion
Simultaneous TE-TGPRK/CXL significantly improved UCVA, BCVA, IS value, and flattened Kmax and Kavg. TE-TGPRK/CXL appears to be a promising treatment for improving visual outcomes and corneal topography in keratoconus and corneal ectasia patients.
Presenting Author
Kenneth A. Beckman, MD, ABO
Co-Authors
Erin Leone PhD, Tomas Navratil PhD, Valerie Smith MBA, George Waring MD, Marco Armijo BA
Purpose
To evaluate the safety and efficacy of iLink non-invasive epithelium-on corneal collagen crosslinking in eyes with progressive keratoconus.
Methods
Phase 3 prospective, multicenter, randomized, sham-controlled trial of 279 eyes from 201 subjects with keratoconus. Eyes were randomized 2:1 to receive iLink (n=189) or sham (n=90). iLink eyes were followed for 12 months. At month 6, sham eyes could receive iLink and be followed to month 12. A total of 277 eyes received iLink treatment, and 2 eyes received only sham treatment. The primary and secondary efficacy endpoints were the change from baseline (CFB) in mean maximum corneal curvature (Kmax) at month 6 and 12, respectively. Missing data imputed via multiple imputation for the month 6 analysis and via last observation carried forward for the month 12 analysis.
Results
At month 6, the mean Kmax had decreased/improved by 0.3D in iLink eyes, increased/worsened by 0.6D in the sham eyes; for a mean difference in CFB in mean Kmax of -1.0D (p=0.0004). At month 12, mean Kmax had decreased/improved by 0.4D in iLink eyes, increased/worsened by 0.7D in the sham eyes for a mean difference in CFB in mean Kmax of -1.1D (p<0.0001). No significant difference in the mean CFB in best spectacle corrected or uncorrected visual acuity between treatment groups at month 6. Adverse events were mostly mild and transient.
Conclusion
iLink corneal crosslinking treatment resulted in a reduction in Kmax while sham treatment resulted in worsening of keratoconus as evidenced by increased Kmax. iLink treatment was safe in eyes with keratoconus.
Presenting Author
Kenneth A. Beckman, MD, ABO
Co-Authors
John Berdahl MD, Erin Leone PhD, Alex Yildizyan BSc, Terence Koritz MBA, Valerie Smith MBA
Purpose
To evaluate the safety and efficacy of iLink epithelium-on corneal collagen crosslinking in pediatric patients with progressive keratoconus from a Phase 3 trial.
Methods
The prospective, randomized, multicenter, sham-controlled, Phase 3 trial enrolled patients with progressive keratoconus. Thirty (30) eyes of 22 pediatric patients aged 12 to 17 years old were randomized 2:1 to iLink non-invasive epithelium-on corneal collagen crosslinking treatment (n=19) or sham treatment (n=11). The primary efficacy endpoint was the mean change from baseline in maximum corneal curvature (Kmax) to month 6. Best corrected visual acuity (BCVA) and adverse events (AE) also were evaluated.
Results
At month 6, the least squares mean change from baseline in Kmax was -0.5 D in iLink eyes compared to 1.5 D in sham eyes for a mean difference in change from baseline in Kmax of -2.0 D (95% confidence interval: -4.6, 0.5). The mean change from baseline in BCVA was 7.9 letters in iLink eyes compared to -6 letters in sham eyes, and 6 of 19 iLink eyes had a 15-letter gain in BCVA compared to 0 of 11 sham eyes. No serious AEs were reported. Ocular AEs occurred in 19 of 19 iLink eyes and 10 of 11 sham eyes; most iLink eye AEs were mild (14 of 19) and most sham eye AEs were moderate (6 of 11).
Conclusion
At 6 months post treatment, non-invasive epithelium-on corneal crosslinking treatment in pediatric patients resulted in a reduction in Kmax and improvement in BCVA compared to sham treatment. iLink epithelium-on corneal crosslinking has the potential to safely and effectively treat keratoconus in pediatric patients.
Presenting Author
Ayah A Marrie, MD
Co-Authors
Mohamed Hosny FRCOphth, FRCSEd, PhD, Mohamed Anis MD, Baheya Salem MD
Purpose
The Sub-400 Protocol of corneal collagen crosslinking (CXL) is a novel technique that allows thin corneas of less than 400 µ to undergo CXL for treatment of keratoconus. Our study aims to evaluate the endothelial cell density of corneas undergoing both Sub 400 and the conventional Dresden protocols.
Methods
Our study included 50 eyes of keratoconus patients undergoing corneal collagen crosslinking. Patients were divided into two groups: Group A, which included 25 eyes with corneal thinnest location point above 400 µ; and Group B, which included 25 eyes with corneal thinnest location point below 400 µ. Group A underwent the Dresden protocol of CXL and Group B underwent the sub-400 protocol. All patients underwent a pre-operative evaluation, as well as a postoperative evaluation at 1 day,1 month, 3 months, 6 months, and 12 months postoperatively. Our 1ry outcome was corneal endothelial cell density, and our 2ry outcomes were BCVA, keratometry and depth of demarcation line.
Results
The mean postoperative change in endothelial cell density in Group A was -22.96±24.65 and -5.12±116.31 cells/mm2 at 1 month and 3 months respectively. It was +13.48±204.79 and +8.00±204.00 cells/mm2 in Group B. There was no significant difference between both groups(P=0.63). The mean postoperative depth of demarcation line was 370.21±27.47 µ in Group A, and 299.16±38.38 µ in Group B (P<0.001). The mean postoperative change in BCVA in Group A was -0.21±0.06 and -0.05±0.07 at 1 month and 12 months respectively. It was -0.12±0.06 and 0.03±0.04 in Group B (P<0.001). There was no significant difference between the changes in K1, K2, or average K of both groups at all visits (P= 0.3,0.5,0.2).
Conclusion
The Sub-400 Protocol of CXL is an equally safe and effective option as the standard Dresden Protocol in the treatment of patients with keratoconus. The Sub-400 Protocol can be safely and effectively used to treat patients with a central corneal thickness of less than 400 µ that the Dresden Protocol cannot safely treat.
Presenting Author
Kangjun Li, MD
Co-Authors
Zheng Wang PhD, Zhanyu Su MD
Purpose
To evaluate corneal tissue and biomechanical enhancement in advanced keratoconus after decellularized allogeneic lenticule implantation (ALI) with or without corneal cross-linking (CXL).
Methods
Interventional comparative, consecutive, randomized, prospective series of cases. A total of 21 advanced keratoconus patients with corneal thickness less than 400?m were randomly distributed into two groups: group1(G1), decellularized allogeneic lenticule implantation (n = 10); group2(G2), decellularized allogeneic lenticule implantation with CXL (n = 11). Preoperative and postoperative visual acuity, manifest refraction spherical equivalent, slit-lamp, in vivo confocal microscopy (IVCM), anterior segment optical coherence tomography (AS-OCT), Pentacam AXL and Corvis ST examinations were all recorded.
Results
A gradual and significant increase (P < 0.001) was observed in the corneal thickness (CT) and stroma roughness index (SRI) of patients in G1 and G2. The corneal stiffness of patients in G2 was statistically significant higher (P = 0.002) than in those in G1. During the 2 years follow-up, no adverse event was observed and lenticules were well positioned into the intrastromal pocket which identified by the slit-lamp and the AS-OCT in G1 and G2. No significant difference in corneal curvatures at the apex, anterior steep keratometry and posterior steep keratometry in two groups (all P > 0.05).
Conclusion
A significant increase in tissue roughness and biomechanical strength up to 2 years at the corneal stroma in advanced keratoconus patients following the decellularized lenticule implantation. In addition, this increase was significantly higher in the ALI with CXL.
Presenting Author
Juliana F. Santos, MD
Co-Authors
Adriana Forseto PhD, MD, Nicolas Pereira PhD, MD, Marcony Santhiago MD, PhD
Purpose
To evaluate the results of corneal crosslinking (CXL) with individualized fluency in patients with corneal ectasia and thin corneas, using hydroxypropylmethylcellulose (HPMC) as a vehicle for riboflavin.
Methods
Prospective interventional study with partial results from 20 eyes of 20 patients with corneal ectasia and documented progression or high risk of progression and with stromal thickness <400 µm without epithelium. The technique used was based on the sub-400 CXL protocol, except by the riboflavin used, with a hydroxypropylmethylcellulose (HPMC) vehicle. The technique includes epithelial debridement, soaking time for 16 minutes with 0.1% riboflavin in 1%HPMC. Then, ultraviolet radiation was applied with individualized irradiation times according to post-soaking paquymetry following the table. Patients were evaluated for 12 months of follow-up.
Results
Of the patients included in the study, 60% were female. Maximum keratometry reduced from 65.66 ± 7.68 preoperatively to 63.11 ± 7.05 at 1-year follow-up, however 3 patients had progression. Although medium endothelial cell count slightly decreased, only one patient had a transient corneal edema, and none of the other patients showed changes on biomicroscopy. Regarding haze, 1 patient developed severe persistent haze with visual acuity impairment and 3 others patients had moderate transient haze. Best corrected visual acuity (BCVA) improved from 0.39 ± 0.35 to 0.35 ± 0.31 after one year of follow-up
Conclusion
Individualized fluency cross-linking technique using HPMC riboflavin had a stabilization rate of 85%, with some related risks and may be an alternative for patients with very thin córneas. Further studies with longer follow-up are necessary to perform the procedure safely.
Presenting Author
Eric Y. Oregon Miranda, MD
Purpose
To assess the safety and efficacy of same day intrastromal rings implantation plus accelerated transepithelial corneal collagen crosslinking on patients diagnosed with keratoconus.
Methods
74 eyes from 37 adult patients were included. Patients eligibility included best corrected visual acuity less than 20/100 with contact lens intolerance and clear cornea with pachimetry equal or more than 380 microns. Patients underwent femtosecond laser assisted keraring implantation (Visumax) followed by corneal accelerated collagen crosslinking (CCL Vario) with the use of transepithelial riboflavin (Peshcke TE).All patients were examined for ophthalmic evaluation including best corrected visual acuity, keratometries, refraction both subjective and cycloplegic, corneal topography and pachimetry, intraocular pressure previous to the procedure and 1, 6, 12 , 24 and 36 months after surgery.
Results
Since 1st month followup main outcomes measures: best corrected visual acuity, keratometries, refraction both subjective and cycloplegic and corneal topography improved compared to 1st visit with their best outcomes continuing even at 36 months (P< />
Conclusion
Corneal intrastromal kerarings insertion with the aid of femtosecond laser plus epi on accelerated crosslinking is a safe and efficacious procedure for keratoconus control at 3 year followup.
