Moderator
Helen K. Wu, MD, ABO
Panelists
Thomas Dohlman, MD, ABO
Anthony J. Aldave, MD, ABO
Viewing Papers
Expand a paper title to the right to view the paper abstract and authors. Use the video link to jump to that poster in the session.
Presenting Author
Manokamna Agarwal, MD
Co-Authors
Ryan Huang MSc, Michael Mimouni MD, Clara Chan MD, FRCSC, David Rootman FRCS, MD
Purpose
To study the effectiveness of penetrating keratoplasty (PK) in patients undergoing cyanoacrylate glue application for corneal perforations or thinning.
Methods
This is a retrospective cohort study including 185 patients who underwent cyanoacrylate glue application with 63 patients receiving subsequent PK either for tectonic or rehabilitation purposes. Patient were divided into 2 groups; PK (n=63) and no PK (n=122). Demographic features, aetiology, location of perforation, times of glue application, pre and post visual acuity, and follow up time were compared between the two groups.
Results
Baseline characteristics including age, gender, laterality and thinning vs. perforation were comparable between the 2 groups (p=0.280, 0.534, 0.541, 0.865 respectively). Patients undergoing PK had significantly worse initial visual acuity (mean logMAR 2.18 vs.1.84, p=0.018) and showed no statistically significant improvement at the final follow-up (mean logMAR 2.21 vs.1.86, p=0.037). Logistic regression analysis revealed lower odds of needing PK if location of glue was peripheral (adjusted OR 0.29, p=0.006). Multiple glue patches, baseline visual acuity >2 logMAR and viral aetiology had higher odds of needing PK (adjusted OR 2.70, 13.45, 4.43 and p=0.003, 0.001, 0.011 respectively).
Conclusion
Patients with severe initial presentation and those requiring multiple glue patches are more likely to undergo PK and tend to have worse visual outcomes. PK offers no significant advantage in visual acuity improvement compared to conservative management. These findings suggest careful consideration for PKP in similar patient populations.
Presenting Author
Haolan Qi, MD, MSc
Co-Authors
Kuangtsan Hsu MD, PhD
Purpose
This study evaluates the predictive power of Critical Flicker Fusion Frequency(CFF) test for visual outcomes in keratoprosthesis(KPro) candidates, comparing its accuracy with B-scan, flash Visual Evoked Potentials(fVEP),and endoscopy. We aim to identify a more precise tool for KPro prognosis when anterior segment opacity hinders visual evaluation.
Methods
This prospective and non-comparative study included 42 patients(42 eyes)scheduled for KPro surgery with a median follow-up of 1 year.In the model development study(17 eyes),the ROC curve identified the cut-off threshold for CFF.In the comparison study(25 eyes),all patients underwent preoperative assessments including trichromatic CFF(Red,Green,Yellow),B-scan ultrasound, fVEP, and endoscopy. Results were classified as either favorable or unfavorable predictors of visual outcomes based on predefined criteria.Sensitivity and specificity of each assessment were calculated based on postoperative BCVA?20/200.The Bland-Altman test assessed the consistency between CFF-predicted BCVA and actual BCVA.
Results
Among the trichromatic CFF tests, the yellow-CFF (yCFF) exhibited the highest AUC value of 0.97 and a cut-off threshold at 10 Hz for predicting postoperative BCVA ? 20/200 (P<0.05). ycff="" achieved="" 90%="" sensitivity="" and="" 80%="" specificity="" in="" predicting="" satisfactory="" postoperative="" outcomes.="" endoscopy="" had="" 80%="" sensitivity="" and="" 80%="" specificity,="" b-scan="" showed="" 70%="" sensitivity="" and="" 60%="" specificity,="" and="" fvep="" had="" 75%="" sensitivity="" and="" 40%="" specificity.="" ycff="" showed="" a="" mean="" bias="" of="" 0.091="" logmar="" in="" postoperative="">
Conclusion
Our results highlight the potential of the CFF in evaluating candidates for KPro surgery, demonstrating its significant ability to predict visual outcomes. The CFF test is a superior predictor of visual outcomes in KPro candidates when compared to B-scan ultrasound, fVEP tests, and endoscopy.
Presenting Author
Amir Abd Elkader, MD
Co-Authors
Mona Harissi-Dagher MD, FRCSC, Wissam Nassrallah MD, PhD, Simon Elsliger MD, Rayan Tolba BSc
Purpose
KPro1 is a synthetic cornea used in cases of corneal blindness to restore vision. While KPro1 can achieve visual acuity better than 20/200, it is associated with known adverse events. This study aims to examine the incidence of retinal detachment following KPro1 implantation, and to identify the risk factors leading to this complication.
Methods
This retrospective study analyzed data from 140 eyes that underwent KPro1 implantation, with an average follow-up period of 7.58 � 4.72 years. The inclusion criteria required 1 year follow-up minimum. The intervention examined was the KPro1 implantation, with the primary outcome measure being the incidence of retinal detachment in the 12 months following implantation of a KPro1 in relation to risk factors such as patient demographic data, clinical data, or other adverse events. Statistical analysis such as chi-squared tests for contingency tables and Kaplan-Meier survival curves were performed using GraphPad PRISM software.
Results
The most common indication for KPro1 was aniridia (24.29%), which was also most associated with retinal detachments (OR of 4.340; p=0.0022**). Retinal detachment occurred in 5.33% of patients one-year post-KPro1 implantation, increasing to 20.10% at 7.5 years of follow-up. No significant difference in retinal detachment rates was observed between patients aged over or under 65
Conclusion
Aniridia was the strongest risk factor for retinal detachment, though approximately 80% of patients remained free of detachment 7.5 years post-KPro1 implantation. Patient age did not significantly impact detachment rates. Given the heightened risk in aniridia patients, special consideration is needed when evaluating KPro1 implantation in this group
Presenting Author
Dominique Geoffrion, MD, PhD
Co-Authors
Mona Harissi-Dagher MD, FRCSC, Younes Agoumi FRCSC, MD, Joseph Hakim MD
Purpose
To compare two frequently used aqueous shunts for the treatment of glaucoma in eyes with Boston keratoprosthesis type 1 (KPro).
Methods
Retrospective comparative study of 37 eyes (36 patients). 32 eyes received the Ahmed FP7 valve (AGV) and 5 eyes received the Baerveldt 101- 350 implant (BGI) at the same time or after KPro. Primary outcome was shunt failure (intraocular pressure [IOP] outside 6-21 mmHg or reduced <20% from="" baseline="" for="" 2="" visits,="" severe="" vision="" loss="" or="" de="" novo="" glaucoma="" surgery).="" secondary="" outcomes="" were="" iop,="" topical="" medication="" use,="" and="" postoperative="">
Results
At 5 years, the cumulative probability of failure was 55% for AGV and 80% for BGI (P=0.204). The most common cause of failure was the need for additional glaucoma surgery (48%). Mean IOP decreased in AGV eyes by 27% (22 to 16 mmHg) at 5 years, and in BGI eyes, by 21% (19 to 15 mmHg) (P=0.607). Medications per eye increased by 2% at 5 years in AGV, while they decreased by 20% in BGI (P=0.281). The major complication for both groups was high IOP (22%).
Conclusion
Both shunts were effective at reducing the IOP in KPro. The BGI had a higher failure rate and lower IOP on fewer glaucoma medications compared to the AGV.
Presenting Author
Dominique Geoffrion, MD, PhD
Co-Authors
Mona Harissi-Dagher MD, FRCSC, Younes Agoumi FRCSC, MD, Georges Durr FRCSC, MD, Marie-Claude Robert MSc, FRCSC, MD, Robert Koenekoop PhD, FRCSC, MD, Adriana Di Polo PhD
Purpose
To characterize the difference in ocular surface inflammation between Boston keratoprosthesis (KPro) and primary angle closure glaucoma patients.
Methods
Prospective cross-sectional study of 68 eyes: 10 controls, 10 primary angle closure glaucoma without KPro (PACG), 41 KPro with glaucoma (KPro G), and 7 KPro without glaucoma (KPro NoG). A multiplex bead immunoassay measured the levels of 27 cytokines in the tear fluid of all eyes. Ancillary testing included visual acuity, intraocular pressure, anterior segment OCT and posterior segment OCT for all patients. Statistical analysis included univariable and multivariable analyses.
Results
All groups had similar age and gender distribution. Mean time from KPro surgery to tear collection was 7.9�3.5 years. Compared to PACG patients, KPro G patients had higher tear levels of IL-1RA (P <0.0001), il-8="" (p="0.002)," il-15="" (p="0.003)" and="" rantes="" (p="0.001)." a="" generalized="" linear="" model="" showed="" that="" kpro="" and="" angle="" status="" were="" significantly="" associated="" with="" il-1ra="" (b="7236,"><0.0001; b="-3846," p="0.005)," il-8="" (b="825.3," p="0.002;" b="-550.7," p="0.03)," and="" rantes="" levels="" (b="12.73," p="0.0008;" b="-10.76," p="0.003)," respectively,="" after="" adjusting="" for="" age,="" gender,="" and="" glaucoma.="" kpro="" status="" was="" associated="" with="" il-15="" (b="3.344," p="0.012)" after="" adjusting="" for="" age,="" gender,="" angle="" and="" glaucoma="">
Conclusion
Results show that KPro G eyes have a particular inflammatory profile compared to PACG. IL-1RA, IL-8, IL-15, and RANTES are elevated in tear fluid of KPro G compared to PACG and may serve as biomarkers. Ocular surface inflammation in KPro eyes may be influenced by angle closure which ought to be managed earlier.
Presenting Author
Lional Raj Daniel Raj Ponniah, MD, PhD
Purpose
To evaluate the safety and effectiveness of implanting a novel synthetic corneal endothelial substitute(endothelial keratoprosthesis) in cases with pseudophakic chronic endothelial dysfunction, and its long-term safety.
Methods
A prospective open-label clinical safety & efficacy evaluation. Endothelial dysfunction following pseudophakic corneal edema which is not associated with systemic diseases like Herpes Simplex or prior corneal surgeries was subjected to a central 6.5 mm synthetic endothelial implantable substitute after a central 7.0mm descemetorhexis & attached with C3F8 gas (85% fill in the AC). Pre & post-operative central pachymetry (in mic.), vision (in ETDRS characters), and pain analog (1-100) were analyzed in addition to re-bubbling rates & toxic reactions due to implants and followed up monthly for 24 months.
Results
12 cases were enrolled. The longest follow-up is 24 months, min. follow-up is 12 months. Baseline vision was 10.54+/-2.2 ETDRS characters, which improved to 41.75+/-8.7 characters by M-1 & retained at 60.72+/-13.1 characters by M-12. Mean Central pachymetry reduced from 720 mic, to 552 mic. by M-1 & maintained at 491 mic. by M-12. The presenting pain was 91.9+/-2.3 & was 7.7+/-2.5 at M-12 (p<0.0001). no="" immunologic="" or="" other="" adverse="" reactions="" were="" noticed.="" none="" were="" explanted.="" 4="" cases="" needed="" re-bubbling="" (d7,="" d7,="" d12="" &="" 21,d7,="" d14&m3).="" subject="" died="" after="" 6="" months,="" postmortem="" hpe="" reports="" revealed="" epithelialization="" &="" fibrosis="" along="" the="" implant="" edges="" favoring="" long-term="" device="">
Conclusion
Endothelial keratoprosthesis improved vision, reduced edema caused in pseudophakic endothelial dysfunctions & was not associated with toxicities until month 24, & is continuously been monitored. Could be alternative to EK with no risks of rejections or graft failures, could change the practice pattern of "Transplant to Implant Science".
Presenting Author
Ivanka J. van der Meulen, MD, PhD
Co-Authors
Ruth Lapid-Gortzak PhD, MD
Purpose
To report the 5 years results of visual acuity and safety of the implantation of the EndoArt (Eye Yon Medical, Israel).
Methods
Consecutive interventional case series. The EndoArt is an acrylic dome-shaped implant with a thickness of 50 microns and a diameter of 6.5 mm diameter, which acts as a physical barrier preventing fluid uptake into the cornea stroma leading to a decrease in corneal thickness. In 10 eyes of 10 patients (7 participated in the first in human study) the EndoArt was implanted for corneal endothelial failure. The first 7 eyes were implanted for a tectonic indication. The 3 eyes implanted later were implanted with a rehabilitative indication. Exclusion for implantation was overly thinned corneas, previous herpetic keratitis, and anterior keratoplasties.
Results
TThe EndoArt remains in situ and clear after successful implantation for up to 5 years. In most patients corneal thickness and stromal edema was reduced. In 5 of 10 patients improved visual acuity was found. No complications related to the implant were seen. Adherence of the device improved with the use of a temporary corneal suturing. The use of a suture significantly reduced the rebubbling rates. The adherence failure rate is 20% in this cohort. This is related to severe posterior corneal irregularity. At 5 years the EndArt shows stable adhesion to the cornea. More study is needed as to durability, stability, implantation indications, and clinical outcomes of this novel device.
Conclusion
The EndoArt remains in situ with reduction of corneal thickness after implantation for up to 5 years. No complications related to the implant were seen. Adherence of the device improved with the use of a temporary corneal suturing. More study is needed as to durability, stability, implantation indications, and clinical outcomes of this device.
Presenting Author
Seyed Reza Ghaffari Dehkharghani, MD
Co-Authors
Ali Masoudi MD, Raul Plasencia Salini MD, Golshan Latifi MD, Anthony Aldave MD
Purpose
To identify the incidence, risk factors, and management outcomes of sterile keratolysis (SK) after Boston type 1 keratoprosthesis (Kpro) implantation.
Methods
Retrospective, consecutive case series of Kpro procedures performed by single surgeon (AJA) at Stein Eye Institute between May 2004 - December 2022. Cases of SK were identified, and the following data collected: ocular history, operative details, postoperative management, treatment and outcomes. Cox proportional hazard ratios (HR) were calculated to evaluate the association of risk factors and outcomes.
Results
270 Kpro procedures (222 eyes, 210 patients) were performed. SK developed following 93 Kpro procedures (34.4%) in 65 eyes (29.3%) of 62 patients (29.5%) during a mean follow-up time of 54.4 � 48.2 months. The mean time to development of SK was 27.7 � 29.0 months, with a calculated incidence of 0.083 per eye-year. Prior Kpro retention failure (HR: 2.70, 95% CI: 1.67-4.39), prior infectious keratitis (HR: 1.97, 95% CI: 1.22-3.19) and cicatricial disease (HR: 1.70, 95% CI: 1.02-2.86) increased the risk of SK. Kpro explantation was required in 75 cases (80.6%) of SK, with Kpro replacement in 47 of the 75 cases (62.7%) and penetrating keratoplasty in 28 of the 75 cases (37.3%).
Conclusion
SK develops in approximately 30% of eyes after Kpro implantation and typically requires Kpro explantation for management. A history of Kro retention failure, cicatricial disease, and prior infectious keratitis are associated with an increased risk of SK, and thus preventative approaches should be employed in patients with these risk factors.
Presenting Author
Elias F. Jarade, MD
Purpose
To report the technique and early outcomes of SMILE patch that were patched at the central cornea post central keratectomy in order to restore corneal surface regularities and to treat the expected hyperopic shift
Methods
After a near total corneal epithelial debridement, the central corneal scar were treated with manual keratectomy at the designated depth and diameter followed by excimer laser photorefractive keratectomy (PTk) to smoothen the surface of the treated area. A SMILE patch that were obtained from cornea after myopic treatment were patched and sutured in place using 10-O nylon suture to cover the central keratectomized area. Soft bandage contact lens was fitted in place followed by topical antibiotic and steroid over 4 weeks. complete eye evaluation was performed preoperatively and postoperatively
Results
Three eyes of 3 consecutive patient were included in this study. 2 eyes were treated for central corneal cheloid reaction and one eye for central corneal herpetic scar. PTK was performed at a depth of 50 microns in the 3 eyes and near 6 diopter corresponding SMILE patched of 6.5 mm optical zone and 8.5 mm diameter were secured centrally. Complete epithelialization was observed in the 3 eyes over a period 6 to 10 days with neither epithelial ingrowth nor interface complications. UCDVA and CDVA improved significantly in the 3 eyes. Corneal regularities and transparency were obtained in the 3 eyes with minimal hyperopic shift
Conclusion
The preliminary results of our study indicate that SMILE patched can be used safely and effectively to improve visual acuity and refractive errors post central keratectomy. Long term follow up and larger population are needed to assess the long term follow up
Presenting Author
Arie L. Marcovich, MD, PhD
Purpose
To report twenty-four months safety and efficacy outcomes of an artificial lamellar implantation (EndoArt�) on the posterior surface of the cornea of adult patients suffering from chronic corneal edema.
Methods
The EndoArt� (EyeYon Medical, Ness Ziona, Israel), functions as a water-impermeable layer that is designed to be attached to the recipient�s posterior cornea, preventing the inflow of aqueous humor into the stroma, and decreasing corneal edema. Long-term efficacy and safety data, available for 17 patients which took part in a multi-center First in Human study (8 patients), in early compassionate cases (2 patients) and in 7 non-commercial post marketing study, is presented. Central corneal thickness (CCT) improvement and stability are discussed. Best corrected visual acuity (BCVA) measured over the 24 months period is presented for patients with visual potential.
Results
A significant improvement in CCT was observed after 1 month and remained stable over 24 months. Mean preoperative CCT of 791�115?m improved to 558�101?m and 569�86?m after 12 and 24 months, respectively (n=17, p value<0.05). of="" 14="" patients="" with="" visual="" potential,="" 9="" regained="" at="" least="" 8="" etdrs="" lines="" and="" 1="" gained="" 5="" etdrs="" lines="" at="" 24="" months.="" three="" patients="" returned="" to="" baseline="" bcva,="" 1="" due="" to="" consistent="" partial="" detachment="" of="" the="" device,="" and="" 2="" due="" to="" persistent="" epithelial="" bullae.="" patient�s="" vision="" deteriorated="" to="" lp="" due="" to="" optic="" atrophy.="" no="" long-term="" complications,="" infections="" or="" inflammation="" related="" to="" endoart�="" implantation="" were="" observed.="" implants="" remained="" transparent="" throughout="" the="">
Conclusion
The EndoArt� implant was found safe and effective, demonstrating an improvement in corneal thickness as well as in visual acuity. Outcomes of 17 early cases, from the beginning of the learning curve reveal that when fully attached, EndoArt� can alleviate corneal edema and maintain a clear and viable cornea over a long-term period.
Presenting Author
Anthony J. Aldave, MD, ABO
Co-Authors
Seyed Reza Ghaffari Dehkharghani MD, Ali Masoudi MD
Purpose
To report the long-term outcomes of the Boston type I keratoprosthesis (Kpro) as the primary penetrating corneal procedure in patients at high risk of keratoplasty failure
Methods
Retrospective review of all Kpro procedures performed by a single surgeon (AJA) from May 2004 to December 2022. Preoperative, intraoperative and postoperative data was collected for all procedures, and analysis performed for the primary outcome measures of interval corrected distance visual acuity (CDVA), Kpro retention and postoperative complications. Outcome measures were compared between eyes in which the Kpro procedure was the primary corneal procedure (no prior keratoplasty) and eyes with one or more keratoplasty (KP) procedures prior to Kpro implantation.
Results
270 Kpro procedures were performed in 222 eyes; 58 in 40 eyes with no prior KP. The most common indications in eyes with no prior KP was limbal stem cell deficiency (15 eyes, 37.5%). While the % of eyes with CDVA ?20/200 was not significantly different between the no prior KP and prior KP groups at 5 years (78% vs 53%; p=0.52), it was at 10 years (100% vs 52%; p=0.03). Retention failure incidence was also significantly higher in eyes with no prior KP (0.127 vs 0.073/eye-year, HR 1.7, CI 1.1-2.6), although the difference was not significant in multivariate analysis (HR 1.2, CI 0.7-1.9). Sterile necrosis (52% vs 30%; p=0.002) was significantly more common in eyes with no prior KP.
Conclusion
Boston keratoprosthesis as the primary penetrating corneal procedure results in a sustained improvement in CDVA in all eyes in which the Kpro was retained for 10 years. Additionally, there was no significant difference in the incidence of retention failure compared to eyes with prior keratoplasty, despite a higher rate of sterile corneal necrosis.
Presenting Author
Ali Masoudi, MD
Co-Authors
Anthony Aldave MD
Purpose
To determine visual outcomes, complications rate and retention failure of Boston type 1 keratoprosthesis in cicatricial disease in comparison to cases without cicatricial disease.
Methods
This retrospective, consecutive case series included all Kpro procedures performed by a single surgeon at the Stein Eye Institute, UCLA, from May 2004 to January 2023. Eyes undergoing Kpro implantation were categorized into two groups: the first included patients with cicatricial diseases (Stevens Johnson Syndrome (SJS), mucous membrane pemphigoid (MMP), chemical injury), while the second consisted of patients without cicatricial disease. Preoperative, intraoperative and postoperative data was collected for all procedures, and analysis performed for the primary outcome measures of interval corrected distance visual acuity (CDVA), Kpro retention and postoperative complications.
Results
281 Kpro procedures (225 eyes, 214 patients) were performed, including 57 (20.2%) in eyes with cicatricial disease (24 chemical burn, 24 SJS, 9 MMP). While the % of eyes with CDVA ?20/200 in the cicatricial and non-cicatricial groups 1 year after surgery was not significantly different (75% vs 62%, p=0.64), it was significantly higher in the cicatricial group at 3 years (72% vs 57%, P=0.05%). Retention failure was also significantly higher in the cicatricial group (64.9% vs 29.9%, p<0.01%), as="" were="" several="" post-operative="" complications,="" including="" sterile="" corneal="" stromal="" necrosis="" (63%="" vs.="" 25%,="" p="0.02)," persistent="" epithelial="" defect="" (63%="" vs.="" 21%,="" p="0.01)" and="" hypotony="" (12%="" vs.="" 6%,="" p="">
Conclusion
Kpro implantation in cicatricial disease is associated with sustained visual improvement through 3 years after surgery. However, given a higher retention failure rate due to an increased incidence of sterile corneal stromal necrosis, we advise caution when considering implantation in younger individuals with cicatricial disease.
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