Evaluating GlicoPro Tear Substitute Derived from Helix aspersa Snail Mucus in Alleviating Severe Dry Eye Disease: A First-in-Human Study on Corneal Esthesiometry Recovery and Ocular Pain Relief.

Background: To evaluate the effects of 10% GlicoPro tear substitute therapy in patients with severe dry eye disease (DED). Methods: In this prospective longitudinal study, 30 individuals receiving 10% GlicoPro four times daily for DED were evaluated. The ocular surface disease index (OSDI) questionnaire, average non-invasive break-up time (A-NIBUT), non-anesthetic and anesthetic corneal esthesiometry (CE), ocular pain, and the presence of conjunctivochalasis (CCH) were used as clinical endpoints. Treatment compliance using dosing diaries and AEs was assessed. Results: A significant improvement was observed in the clinical endpoints: the ΔOSDI questionnaire was -39.27 ± 13.22 [-65 to -15] points, ΔA-NIBUT was 3.10 ± 1.31 [1 to 5] s, Δnon-anesthetic CE was 14 ± 6.35 [5 to 25] mm, and Δanesthetic CE was 13 ± 5.35 [5 to 20] mm (p < 0.001 for all comparisons). Ocular pain was reduced in 92.5% of the patients at the end of the follow-up. However, there was no change in the presence of CCH. In addition, all the patients were fully compliant with the dosing and no AEs related to the use of the 10% GlicoPro tear substitute were reported. Conclusions: The 10% GlicoPro tear substitute has the potential to achieve beneficial effects in ocular surface treatments.

Functional Classification of Intraocular Lenses Based on Defocus Curves: A Scoping Review and Cluster Analysis.

PURPOSE: To explore a potential functional classification of intraocular lenses (IOLs) based on monocular visual acuity defocus curves (VADCs) as a primary end-point. METHODS: A systematic literature search was conducted using PubMed. Two independent reviewers screened the literature for inclusion and data extraction. Inclusion criteria were full-text primary clinical studies of IOLs, published in English from 2010 onward, involving patients undergoing cataract or refractive lens exchange. A cluster analysis was conducted to explore similarities in the range of field (RoF) and increase of visual acuity from intermediate to near (ΔVA). RESULTS: A total of 107 studies were ultimately included from the 436 identified in the systematic search, with an additional 5 studies added through the snowballing technique search. The cluster analysis was conducted using 69 reports that included monocular VADCs. Two main categories were identified based on the achieved RoF for 0.2 and 0.3 logMAR: full (FRoF) and partial (PRoF) RoF IOLs. Three subcategories were identified for FRoF depending on ΔVA: continuous (FRoF-C), smooth (FRoF-Sm), and steep (FRoF-St). On the other hand, PRoF IOLs shared the characteristic of monotonous decrease in visual acuity and were subclassified into two subcategories depending on the achieved RoF: narrowed (PRoF-N) and extended (PRoF-Ex). An additional subcategory was added to PRoF, enhanced (PRoF-En), for 7 reports alternating between PRoF-N and PRoF-Ex depending on the use of 0.2 or 0.3 logMAR as a cut-off for calculating the RoF. CONCLUSIONS: IOLs can be functionally classified into six types depending on the RoF and shape of the monocular VADC. [J Refract Surg. 2024;40(2):e108-e116.].

Topical Antiseptics in Minimizing Ocular Surface Bacterial Load Before Ophthalmic Surgery: A Randomized Controlled Trial.

PURPOSE: To investigate the reduction of the ocular surface bacterial load induced by 2 commercially available ophthalmic antiseptic formulations, povidone-iodine (PVI) 0.6% and chlorhexidine (CLX) 0.02%, before ocular surgery. DESIGN: Randomized controlled trial. METHODS: Seventy adult patients undergoing intraocular surgery (phacoemulsification) were randomized to receive in the index eye PVI (group A) 4 times a day for 3 days or CLX (group B) 4 times a day for 3 days before surgery. The untreated eye was used as control. A conjunctival swab was taken in both eyes before (T0) and after (T1) therapy. Microbial DNA was quantified with real-time polymerase chain reaction (PCR) analysis. The Mick algorithm was used to compare the abundance of each genus/genera against the distribution of abundances from the reference. At T1, patients filled a questionnaire to evaluate therapy-induced symptoms. Primary outcome was the reduction of bacterial DNA at T1 (microbial load), vs control arm, expressed as mean number of real-time PCR cycle times (CTs). Secondary outcomes were taxonomic composition, differential abundance, and therapy-induced ocular symptoms. RESULTS: The T0-T1 difference in CT was significant in group B, but not in group A (mean [95% CI], 0.99 [0.33] vs 0.26 [0.15], P < .001, and 0.65 [0.3] vs 0.45 [0.41], P = .09, respectively). The taxonomic composition, alpha, and beta diversity remained consistent at all time points in both groups. The rate of patients reporting therapy-induced ocular symptoms and the mean discomfort grade were greater in group A than in group B (97% vs 26% and 4.97±2.48 vs 0.66±1.53, respectively). CONCLUSIONS: Compared with PVI 0.6%, CLX 0.02% induced a greater reduction of ocular surface bacterial load, with no significant alterations of the taxonomic composition. Moreover, CLX was better tolerated than PVI.

The Influence of Lid-Parallel Conjunctival Folds and Conjunctivochalasis on Dry Eye Symptoms with and Without Contact Lens Wear: A Review of the Literature.

INTRODUCTION: Lid-parallel conjunctival folds (LIPCOF) and conjunctivochalasis (CCH) are similar conditions that seem to be related to dry eye severity. In addition, there is a lack of studies on the topic of LIPCOF and CCH on dry eye symptoms in non-contact lens and contact lens (CL) wearers. Therefore, the aim of this study is to review the relationship of LIPCOF and CCH with dry eye symptoms in non-CL and CL wearers, as well as to report the treatment of dry eye disease (DED) in non-CL and CL wearers who present LIPCOF or CCH. METHODS: A literature review of full-length original studies in two databases, PubMed and Scopus, was performed. The search period included observational studies in humans published between April 21, 2009 and March 20, 2023. RESULTS: A total of 26 studies were included. The studies suggest that LIPCOF and CCH are significantly related to dry eye symptoms in non-CL and CL wearers. However, the impact of CL wear on LIPCOF and CCH may be complex and may vary depending on individual factors such as lens type, lens care regimen, and pre-existing ocular conditions. Regarding LIPCOF management, tear substitutes seem to significantly reduce LIPCOF and dry eye symptoms in non-CL wearers, while vectored thermal pulsation (VTP) and microblepharoexfoliation (MBE) are suggested as promising treatment for LIPCOF and dry eye symptoms in CL wearers. Regarding CCH management, surgical interventions may be effective in reducing CCH when medical treatments have no response. In addition, an ocular examination by slit lamp is necessary to distinguish both conditions. CONCLUSIONS: Tear substitutes, VTP, MBE, and fitting CLs with low coefficient of friction (CoF) seem to reduce and prevent LIPCOF. However, surgical treatment options seem to be more effective in the complete elimination of CCH. An adequate evaluation and differentiation between LIPCOF and CCH are important, and they should be considered by practitioners in managing dry eye symptoms in non-CL and CL wearers.

Screening of positive dysphotopsia before multifocal intraocular lens implantation.

PURPOSE: To assess the photic phenomena (PP) and positive dysphotopsia in candidates for presbyopia or cataract surgery and to evaluate their relationship with cataract grading systems. DESIGN: Retrospective observational. METHODS: Monocular data for 82 subjects measured during the preoperative screening were retrospectively retrieved from our database. The evaluated variables consisted of two methods for PP measurement: light distortion index (LDI) and parameters obtained from a simulator, both of which were combined with subjective bother related to PP. The cutoff for LDI that better predicted patients passing from slightly to moderately bothersome was estimated. The relationships between LDI and the following objective cataract grading methods were also assessed: objective scatter index (OSI), dysfunctional lens index (DLI), and Pentacam Nucleus Staging (PNS). RESULTS: LDI was the best method for measuring PP, which showed a significant correlation with the bothersome question (rho = 0.34, P = 0.002) and also with OSI (rho = 0.67, P < 0.0005), DLI (rho = -0.29, P = 0.007), and PNS (rho = 0.48, P < 0.0005). The number/percentage of patients who found it bothersome was as follows: "Not at all" (18/22%), "Slightly" (41/50%), "Moderately" (15/18.3%), and "Very" (8/9.7%). The cutoff value that predicted the transition from slightly to moderately bothersome was ≥15.20% according to LDI, which could be estimated with the following values for grading: ≥2.8 for OSI, ≤7.6 for DLI, and ≥2 for PNS. CONCLUSIONS: Patients reporting moderately or higher bothersome levels in the preoperative period and with LDI <15.20%, <2.8 for OSI, >7.6 for DLI, and <2 for PNS might deserve special attention in the multifocal intraocular lens selection.

Efficacy of bilateral OC-01 (varenicline solution) nasal spray in alleviating signs and symptoms of dry eye disease: A systematic review.

PURPOSE: To comprehensively review the efficacy and safety of OC-01 varenicline nasal spray versus vehicle nasal spray (VNS) in the treatment in dry eye disease (DED). METHODS: A systematic review that included full-length randomized controlled studies (RCTs), as well as post hoc analyses of RCTs reporting new findings on OC-01 VNS treatment in three databases, PubMed, Scopus and Web of Science, was performed according to the PRISMA statement. The search period included studies published between December 2021 and September 2023. The Cochrane risk of bias tool was used to analyze the quality of the studies selected. RESULTS: A total of 8 studies were included in this systematic review. OC-01 VNS treatment achieved higher improvement than vehicle in all reported variables. The mean differences between both groups were in favor of OC-01 VNS treatment and were as follow: eye dryness score base on a visual analogue scale (EDS-VAS) of -7.5 ± 2.2 points [-11.6 to -5.6], Schirmer test (ST) with anesthesia of 6.6 ± 2.3 mm [4.9 to 11.8] and total corneal fluorescein staining (tCFS) of -1.2 ± 0.01 points [-1.2 to -1.1]. Similar improvements were reported with OC-01 VNS 0.03 mg and 0.06 mg. Adverse events (AEs) were 15.5 ± 19.4 % [-13 to 80.5] higher in the OC-01 VNS group with an overall adherence > 93 %. CONCLUSIONS: OC-01 VNS improves dry eye symptoms and signs with a satisfactory tolerability. Therefore, OC-01 VNS seems to be a safe and effective treatment that could be recommended in patients with DED. This new treatment could be particularly useful in those patients who have difficulties with the administration of traditional topical therapies.

Efficacy of meibomian gland expression combined with Home-Based therapy in the management of dry eye Disease: A systematic review and Meta-Analysis.

PURPOSE: To compare the effectiveness of meibomian gland expression (MGX) combined with home-based therapy versus home-based therapy alone for the treatment of dry eye disease (DED) caused by meibomian gland dysfunction (MGD). METHODS: A systematic review of randomized controlled studies (RCTs), reporting the effects of MGX combined with home-based therapy in 2 databases, PubMed and Web of Science, was performed according to the PRISMA statement. The search period was until August 20, 2023. According to the heterogeneity, a random or fixed effects model was performed in the meta-analysis. The standardized mean difference (SMD) was calculated to analyze dry eye symptoms (DES) score, tear film break-up time (TBUT), total corneal fluorescein staining (tCFS) and meibomian glands expressibility (MGE). All analyses were performed by RevMan Web, version 5.7. The Cochrane risk of bias tool was used to analyze the quality of the studies selected. RESULTS: Two RCTs with a total of 99 patients were included. The studies reported that MGX combined with home-based therapy improves DES score, TBUT, tCFS and MGE compared to the home-based therapy. However, the meta-analysis indicated that MGX combined with home-based therapy only seems to be beneficial in reducing DES score (SMD -0.49; 95 % CI: -0.89 to -0.08; P = 0.02; I2 = 0 %). In addition, although TBUT, tCFS and MGE reported a slight trend in favor of MGX combined with home-based therapy, it was non-significant. CONCLUSIONS: While MGX combined with home-based therapy seem to show some evidence of alleviating dry eye symptoms, there is insufficient evidence to conclude the effects of this treatment definitively particularly in improving dry eye signs caused by MGD, such as TBUT, tCFS and MGE. Therefore, further RCTs are needed to elucidate these results.

Efficacy and Safety of Quantum Molecular Resonance Electrotherapy in Patients with Aqueous-Deficient, Evaporative and Mixed-Type Dry Eye: A Randomized Interventional Study.

INTRODUCTION: To evaluate the efficacy and safety of Quantum Molecular Resonance (QMR) treatment in patients with severe dry eye disease (DED), as well as its effects on aqueous-deficient (ADDE), evaporative (EDE), and mixed (MDE) dry eye. METHODS: In this prospective, interventional study, 81 patients were randomly allocated to received four treatment sessions of QMR at 1-week intervals (Rexon-Eye®, Resono Ophthalmic, Trieste, Italy) (QRM group) or tear substitute four times daily, containing 0.15% sodium hyaluronate and 3% trehalose (Thealoz Duo®, Thea Pharma, France) (SH-TH group). Outcome measures included ocular surface disease index (OSDI) questionnaire, tear meniscus height (TMH), tear breakup time (TBUT), non-invasive breakup time (NIBUT), corneal fluorescein staining (CFS), lipid layer thickness (LLT), tear film osmolarity (OSM), and meibomian gland dysfunction (MGD) grade, which were assessed at baseline and 1-month and 3-month follow-up. RESULTS: The QMR group achieved better improvements than the SH-TH group in OSDI and SANDE questionnaires, NIBUT, LLT, and CFS. The mean differences between the groups were as follows: OSDI (- 12.4 ± 0.25 points, P = 0.01), SANDE (10.6 ± 1.7 points, P = 0.01), NIBUT (2 ± 0.25 s, P = 0.01), LLT (18.7 ± 0.7 nm, P = 0.01), and CFS (1.2 ± 0.1 points, P = 0.02). In subgroups analysis, QMR treatment demonstrated a beneficial role to improve DED symptoms and signs in ADDE, EDE, and MDE. CONCLUSION: QMR is an effective and well-tolerated treatment that seems to improve DED symptoms and signs in patients with severe DED. However, further studies are needed to confirm this. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT06119386.

Assessing the Effects of 0.3% Carboxymethylcellulose Tear Substitute Treatment on Symptoms and Signs of Dry Eye Disease in Elderly Population: A Prospective Longitudinal Study.

BACKGROUND: We aimed to evaluate the effects of 0.3% carboxymethylcellulose (CMC) tear substitute treatment in dry eye disease (DED), as well as treatment compliance and adverse events (AEs). METHODS: In this prospective, longitudinal study, a total of 30 eyes receiving 0.3% CMC tear substitute four times daily for DED were evaluated. Clinical endpoints included an ocular surface disease index (OSDI) questionnaire, average non-invasive tear film break-up time (A-NIBUT), lipid layer thickness (LLT), and a Schirmer test with anesthesia (ST). Treatment compliance and AEs were also assessed. All evaluations were performed at 2, 4, and 12 weeks of follow-up. RESULTS: At the end of the follow-up, significant improvement was observed in all clinical endpoints with the following mean values: ΔOSDI questionnaire of -22.53 ± 14.68 points, ΔA-NIBUT of 4.81 ± 2.88 s, ΔLLT of 5.63 ± 6.53 nm, and ΔST of 2.8 ± 2.1 mm (p < 0.001 for all comparisons). Although repeated measures analysis showed that all clinical endpoints presented statistically significant differences (p < 0.001 for all comparisons LLTBaseline-LLT2-weeks (p = 0.460) and LLT4-weeks-LLT12-weeks (p = 0.071) were the only pairs of measures that reported non-statistically significant differences). In addition, treatment compliance was 94.3 ± 5.2% and transient AEs related to the use of 0.3% CMC tear substitute were reported. CONCLUSIONS: 0.3% CMC tear substitute treatment seems to achieve beneficial effects on the OSDI questionnaire, A-NIBUT, LLT, and ST. However, further studies at this concentration are needed to confirm these results.

Dry Eye Para-Inflammation Treatment: Evaluation of a Novel Tear Substitute Containing Hyaluronic Acid and Low-Dose Hydrocortisone.

Purpose: The purpose of this study was to check the efficacy and safety of a novel tear substitute containing hyaluronic acid and low-dose hydrocortisone in the treatment of moderate dry eye disease. Methods: In this prospective randomized study, 38 patients with moderate dry eye disease were divided into two treatment groups: Group 1 received one drop of 0.2% sodium hyaluronate and 0.001% hydrocortisone four times daily for 3 months, while Group 2 received 0.15% sodium hyaluronate and 3% trehalose at the same dosage. OSDI and SANDE questionnaires, Non-Invasive Break-Up time (NIBUT), Tear Meniscus Height (TMH), meibography, Lipid Layer Thickness (LLT), Tear Break-Up Time (TBUT), Corneal Staining Score (CFS), and Intraocular Pressure (IOP) were evaluated at baseline and after 1, 2, and 3 months of treatment. Results: During the treatment period, Group 1 showed statistically significant improvement in OSDI score (p = 0.002), SANDE score (p = 0.01), NIBUT (p < 0.0001), LLT (p < 0.0001), TBUT (p = 0.01), and CFS (p = 0.02). In Group 2, significant improvement was observed only in the TBUT score (p < 0.05). Comparison of the two groups showed that NIBUT and LLT were significantly different at the end of treatment (p = 0.001 for both comparisons), with more favorable results for sodium hyaluronate and hydrocortisone than for sodium hyaluronate and trehalose. No significant variations in intraocular pressure were observed in either group during the treatment period (p > 0.05). Conclusions: The study confirms that a 3-months treatment with hyaluronic acid 0.2% in combination with low-dose hydrocortisone 0.001% improves the signs and symptoms of moderate DED and that a low-dosage 0.001% hydrocortisone can be helpful in preventing the progression to chronic stages of DED.

Structural and Functional Retinal Changes in Patients with Mild Cognitive Impairment with and without Diabetes.

Our objective is to analyze retinal changes using optical coherence tomography angiography (OCT-A) in patients with mild cognitive impairment (MCI) to characterize structural and vascular alterations. This cross-sectional study involved 117 eyes: 39 eyes from patients with MCI plus diabetes (DM-MCI), 39 eyes from patients with MCI but no diabetes (MCI); and 39 healthy control eyes (C). All patients underwent a visual acuity measurement, a structural OCT, an OCT-A, and a neuropsychological examination. Our study showed a thinning of retinal nerve fiber layer thickness (RNFL) and a decrease in macular thickness when comparing the MCI-DM group to the C group (p = 0.008 and p = 0.016, respectively). In addition, an increase in arteriolar thickness (p = 0.016), a reduction in superficial capillary plexus density (p = 0.002), and a decrease in ganglion cell thickness (p = 0.027) were found when comparing the MCI-DM group with the MCI group. Diabetes may exacerbate retinal vascular changes when combined with mild cognitive impairment.

Scheimpflug Corneal Densitometry Patterns at the Graft-Host Interface in DMEK and DSAEK: A 12-Month Longitudinal Comparative Study.

BACKGROUND: To compare corneal densitometry (CD) patterns at the graft-host interface between Descemet Membrane Endothelial Keratoplasty (DMEK) and Descemet Stripping Automated Endothelial Keratoplasty (DSAEK). Corneal densitometry is a quantitative assessment that objectively evaluates corneal clarity and optical quality by measuring the light backscatter from the cornea. METHODS: Fifty-one eyes that received DMEK or DSAEK surgery for corneal endothelium dysfunction were evaluated. The primary endpoint included CD patterns at the graft-host interface, which were assessed by the Pentacam HR device at the center point of the corneal horizontal meridian (CDcentral), and at six points on the central circumference of the cornea (with a total diameter of 4 mm) (CDI,II,III,IV,V,VI). Secondary endpoints included the best-corrected distance visual acuity (BCDVA), central corneal thickness (CCT), and graft thickness (GT). All of the evaluations were performed at follow-up appointments one, three, six and twelve months after the procedure. RESULTS: DMEK showed a significant overall CD reduction of -7.9 ± 8.5 grayscale unit (GSU) compared to DSAEK (p < 0.001). In addition, the DMEK group showed significantly lower CDCentral,I,II,III,IV,V,VI values at follow-up appointments one, three, six and twelve months after the procedure compared to the DSAEK group (p < 0.001). BCDVA, CCT and GT were in favor of the DMEK group with a mean value of 0.39 ± 0.35 LogMar, 552.2 ± 71.1 µm and 11.03 ± 1.4 µm, respectively (p < 0.001). CONCLUSIONS: CD patterns at the graft-host interface seem to be different depending on the endothelial keratoplasty procedure. This provides specific insight into CD changes in this critical region of surgery, which may provide a better understanding of the postoperative evolution of these patients.

The Efficacy and Safety of Rebamipide Ophthalmic Suspension (OPC-12759) in Patients with Dry Eye Disease: A Systematic Review of Randomized Controlled Trials.

The aim of this paper is to evaluate the efficacy and safety of Rebamipide (REB) ophthalmic suspension in dry eye disease (DED). A systematic review that only included full-length randomized controlled studies (RCTs) reporting the effects of REB ophthalmic suspension in three databases, PubMed, Scopus and Web of Science, was performed according to the PRISMA statement. The Cochrane risk of bias tool was used to analyze the quality of the studies selected. A total of seven studies were included in this systematic review. Although the overall risk of bias was low, most studies were sponsored by the manufacturer. REB ophthalmic suspension treatment achieved higher improvement than the control group in all reported variables. The mean differences between both groups were in favor of the REB group and were as follows: dry eye-related quality of life score (DEQS) -3.5 ± 2.9 points, tear film break-up time (TBUT) of 0.7 ± 0.6 s, Schirmer test (ST) without anesthesia of 0.3 ± 0.6 mm and total corneal fluorescein staining (tCFS) of -1.2 ± 0.7 points. Adverse events (AEs) were 5.2 ± 7.6% superior in the REB group, with an overall compliance > 95%. Therefore, REB ophthalmic suspension is a safe and effective treatment that could be recommended in patients with DED.

Descemet membrane endothelial keratoplasty combined with presbyopia-correcting and toric intraocular lenses - a narrative review.

Fuchs endothelial corneal dystrophy (FECD) is the leading indication for EK and may coexist with cataract and presbyopia. Notably, the outcomes of phacoemulsification in FECD patients are not as favorable as those in eyes without this condition. Historically, only monofocal intraocular lenses (IOLs) were recommended for these patients. However, recent reports have described the implantation of Premium-IOLs (such as Multifocal IOLs, Enhanced Depth of Focus IOLs, and Toric IOLs) in FECD eyes undergoing cataract surgery and Descemet membrane endothelial keratoplasty (DMEK). While the results are encouraging, they are not as optimal as those from unoperated eyes, especially when comparing simultaneous procedures to sequential ones. It's advised to perform the DMEK first to improve the accuracy of IOL calculations. Still, even successfully operated eyes may experience secondary graft failure or graft rejection after DMEK. The success rate of a secondary DMEK is typically lower than that of the initial procedure. Furthermore, if the postoperative thickness after DMEK is less than anticipated, laser enhancements might not be an option. There's a pressing need for more controlled and randomized clinical trials to ascertain the safety and effectiveness of Premium-IOLs for FECD eyes. This narrative review aims to collate evidence on the use of Premium IOL technologies in eyes receiving EK and to underscore key points for surgeons performing EK combined with cataract surgery.

Ocular Surface Microbiota in Naïve Keratoconus: A Multicenter Validation Study.

In the field of Ophthalmology, the mNGS 16S rRNA sequencing method of studying the microbiota and ocular microbiome is gaining more and more weight in the scientific community. This study aims to characterize the ocular microbiota of patients diagnosed with keratoconus who have not undergone any prior surgical treatment using the mNGS 16S rRNA sequencing method. Samples of naïve keratoconus patients were collected with an eNAT with 1 mL of Liquid Amies Medium (Copan Brescia, Italy), and DNA was extracted and analyzed with 16S NGS. The microbiota analysis showed a relative abundance of microorganisms at the phylum level in each sample collected from 38 patients with KC and 167 healthy controls. A comparison between healthy control and keratoconus samples identified two genera unique to keratoconus, Pelomonas and Ralstonia. Our findings suggest that alterations in the microbiota may play a role in the complex scenario of KC development.

Preoperative surgeon evaluation of corneal endothelial status: the Viability Control of Human Endothelial Cells before Keratoplasty (V-CHECK) study protocol.

INTRODUCTION: The success of keratoplasty strongly depends on the health status of the transplanted endothelial cells. Donor corneal tissues are routinely screened for endothelial damage before shipment; however, surgical teams have currently no means of assessing the overall viability of corneal endothelium immediately prior to transplantation. The aim of this study is to validate a preoperative method of evaluating the endothelial health of donor corneal tissues, to assess the proportion of tissues deemed suitable for transplantation by the surgeons and to prospectively record the clinical outcomes of a cohort of patients undergoing keratoplasty in relation to preoperatively defined endothelial viability. METHODS AND ANALYSIS: In this multicentre cohort study, consecutive patients undergoing keratoplasty (perforating keratoplasty, Descemet stripping automated endothelial keratoplasty (DSAEK), ultra-thin DSAEK (UT-DSAEK) or Descemet membrane endothelial keratoplasty) will be enrolled and followed-up for 1 year. Before transplantation, the endothelial viability of the donor corneal tissue will be evaluated preoperatively through trypan blue staining and custom image analysis to estimate the overall percentage of trypan blue-positive areas (TBPAs), a proxy of endothelial damage. Functional and structural outcomes at the end of the follow-up will be correlated with preoperatively assessed TBPA values. ETHICS AND DISSEMINATION: The protocol will be reviewed by the ethical committees of participating centres, with the sponsor centre issuing the final definitive approval. The results will be disseminated on ClinicalTrials.gov, at national and international conferences, by partner patient groups and in open access, peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05847387.

Refraction and defocus curves in eyes with monofocal and multifocal intraocular lenses

Several clinical techniques have been described to evaluate visual performance and optical quality with intraocular lenses (IOL). However, subjective refraction remains one of the most important methods for assessing post-surgery results, taking decisions about retreatments, advanced spectacle prescription and the refinement of the constant for the formula used in the IOL power calculation. Beyond clinical refraction, defocus curve measurement has been described as a complementary tool for assessing visual performance and taking clinical decisions. However, to date, there are no clinical guidelines or evidence-based protocols published in the scientific literature recommended for pseudophakic patients implanted with either monofocal or multifocal IOLs. This narrative review highlights the importance of clinical refraction in pseudophakic eyes, its utility in the decision of different types of IOL implantation, and describes a clinical refraction protocol for eyes implanted with monofocal and multifocal IOLs. (AU)