Factors influencing willingness to participate in ophthalmic clinical trials and strategies for effective recruitment.

AIM: To explore the factors influencing individuals' willingness to participate in ophthalmic clinical trials. METHODS: A questionnaire survey was conducted from January to April 2021 among patients and their family members at Zhongshan Ophthalmic Center, Sun Yat-sen University, in Guangzhou, China. The survey gathered data on respondents' willingness, demographic and socioeconomic profiles, as well as their reasons and concerns regarding engagement in clinical trials. RESULTS: Of the 1078 residents surveyed (mean age 31.2±13.1y; 65.8% females) in Guangzhou, 749 (69.5%) expressed a willingness to participate in future ophthalmic clinical trials. Specific characteristics associated with greater willingness included a younger age, lower annual income, higher education, prior participation experience, previous ophthalmic treatment, and a better understanding of clinical trials. With the exception of age, these characteristics were significantly linked to a higher willingness. The primary barrier to participation, expressed by 64.8% of those willing and 54.4% of those unwilling, was "Uncertain efficacy". In terms of motivations, the willing group ranked "Better therapeutic benefits" (35.0%), "Professional monitoring" (34.3%), and "Trust in healthcare professionals" (33.1%) as their top three reasons, whereas the unwilling participants indicated "Full comprehension of the protocol" (46.2%) as the key facilitator. CONCLUSION: This study reveals a substantial willingness to participate in ophthalmic clinical trials and demonstrates the predictive role of demographic and socioeconomic factors. Variations in motivators and concerns between willing and unwilling participants highlight the significance of tailored recruitment strategies. Importantly, the need for and trust in healthcare professionals stand out as powerful motivations, underscoring the importance of enhancing physician-patient relationships, adopting patient-centered communication approaches, and addressing individualized needs to improve accrual rates.

Building prediction models of clinically significant intraocular lens tilt and decentration for age-related cataract.

PURPOSE: To explore the risk factors and construct nomogram models to predict the risks of clinically significant intraocular lens (IOL) tilt and decentration after cataract surgery in patients with age-related cataract. SETTING: Zhongshan Ophthalmic Center, Guangzhou, China. DESIGN: Prospective cohort study. METHODS: 207 patients (207 eyes) who underwent phacoemulsification combined with IOL implantation were enrolled in the study. Casia2 was used to measure the tilt and decentration of crystalline lenses and IOLs before and 3 months after surgery. Univariate and multivariate logistic regression analyses were used to determine the risk factors of clinically significant IOL tilt and decentration, and nomogram prediction models were constructed according to the results of the multivariate logistic regression analysis. RESULTS: Two hundred and seven patients were included in analysis. 24 eyes (11.59%) and 16 eyes (7.73%) had clinically significant IOL tilt and decentration at 3 months after cataract surgery. Multivariate logistic regression analysis revealed that preoperative crystalline lens tilt and decentration were the risk factors for clinically significant IOL tilt (odds ratio [OR], 3.519, P < .001) and decentration (OR, 410.22, P = .001), respectively. Axial length was another association factor for clinically significant IOL decentration (OR, 2.155, P = .019). The risk models demonstrated good calibrations and discriminations for the predictions of clinically significant IOL tilt (receiver operating characteristic [ROC] area = 0.833, cutoff value = 6.5) and decentration (ROC area = 0.757, cutoff value = 0.08). CONCLUSIONS: The good performances of our models suggested that they may be useful risk prediction tools for postoperative IOL tilt and decentration. The measurement of preoperative crystalline lens tilt and decentration should be one of the routine examinations before cataract surgery, especially for toric and multifocal IOLs.

Early-Onset Posterior Capsule Opacification: Incidence, Severity, and Risk Factors.

INTRODUCTION: To evaluate the incidence, severity, and risk factors of early-onset posterior capsule opacification (PCO) following uneventful phacoemulsification and intraocular lens (IOL) implantation. METHODS: Patients with cataracts who underwent phacoemulsification and IOL implantation surgery for 3 months from September 2019 to April 2020 were enrolled. All the subjects completed a comprehensive ocular examination. Retroillumination images of the posterior capsule were obtained using a slit lamp with imaging system, and PCO was graded by two ophthalmologists. Univariate and multivariate logistic regression analyses were performed to assess the risk factors for PCO. RESULTS: A total of 1039 subjects were enrolled, with mean age 66.68 ± 11.43 years and 42.06% were male. The incidence of early-onset PCO in the 3 months after cataract surgery was 29.93%, and PCO of grade 3 and grade 4 was present in 31 patients (2.98%). Patients with complicated cataract had a higher incidence of PCO than age-related cataract, especially for patients with previous pars plana vitrectomy (PPV) surgery (P < 0.001). Moreover, the incidence of PCO increased with the deficiency of capsulorhexis-IOL overlap (P < 0.001). Multivariate logistic regression also showed that previous PPV surgery (OR 2.664, P = 0.003) and incomplete capsulorhexis-IOL overlap were risk factors for PCO (180-360° overlap: OR 2.058, P < 0.001; < 180° overlap: OR 5.403, P < 0.001). CONCLUSIONS: Larger capsulorhexis and PPV surgery history contribute to the occurrence of early-onset PCO, indicating that primary posterior continuous curvilinear capsulorhexis can be considered during cataract surgery for patients with PPV history.

Incidence of Incision-Related Descemet Membrane Detachment Using Phacoemulsification With Trapezoid vs Conventional 2.2-mm Clear Corneal Incision: A Randomized Clinical Trial.

IMPORTANCE: The conventional 2.2-mm clear corneal incision is relatively narrow compared with the sleeves of Phaco handpieces, resulting in friction at the incision site and increased risk of incision-related Descemet membrane detachment (DMD). The modified 2.2-mm incision only enlarged internal width to 3.0 mm, forming a trapezoid incision shape, which may reduce the friction of surgical instruments and decrease the risk of incisional DMD. OBJECTIVE: To compare the incidence of incision-related DMD between eyes undergoing modified vs conventional 2.2-mm incision phacoemulsification for hard nuclear age-related cataract. DESIGN, SETTING, AND PARTICIPANTS: This double-masked, parallel randomized clinical trial was conducted from July 22, 2019, to January 22, 2020, at Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China. The study included patients with age-related cataract and nuclear opalescence grade of 4.0 or greater based on the Lens Opacities Classification System III. Patients were enrolled in this study according to the following inclusion criteria: (1) age between 65 to 90 years; (2) pupil size of 6 mm or greater after dilation; (3) Lens Opacities Classification System III nuclear opalescence grade of 4.0 or more; and (4) corneal endothelial cell density greater than 1500 cells/mm2. INTERVENTIONS: Modified (enlarged internal width to 3.0 mm) or conventional 2.2-mm incision phacoemulsification with intraocular lens implantation. MAIN OUTCOMES AND MEASURES: Incidence of incision-related DMD at postoperative day 1. RESULTS: A total of 130 eyes of 130 patients were randomized into the conventional group (n = 65) or the modified group (n = 65). The mean (SD) age of participants was 74.5 (5.9) years and 74.3 (6.0) years in the conventional and modified groups, respectively. A total of 26 participants in the conventional group (40%) and 27 in the modified group (42%) were men. Compared with eyes in the conventional group, the incidence of DMD in eyes in the modified group was significantly lower at postoperative day 1 (difference, 26.15; 95% CI, 9.60-42.71; P = .003). The difference at postoperative day 7 was 16.92 (95% CI, 2.91-30.94; P = .02). The length of DMD (postoperative day 1: difference, 0.188; 95% CI, 0.075-0.301; P = .002) and maximal corneal thickness at incision site (postoperative day 1: difference, 0.032; 95% CI, 0.006-0.057; P = .02; postoperative day 7: difference, 0.019; 95% CI, 0.003-0.035; P = .02) were lower in the modified group, while visual quality parameter modulation transfer function (postoperative day 1: difference, -0.033; 95% CI, -0.064 to -0.001; P = .04) was higher. No difference was observed between the 2 groups in best-corrected visual acuity, central corneal endothelium loss, or surgically induced astigmatism at any follow-up time. There were no intraoperative complications in the 2 groups. CONCLUSIONS AND RELEVANCE: These findings suggest that modified 2.2-mm trapezoid incision phacoemulsification reduces the incidence of DMD for hard nuclear age-related cataract at postoperative day 1 and might be considered in patients at high risk of incision-related DMD, although the clinical relevance cannot be determined with certainty from this trial. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04014699.

Distributions of crystalline lens tilt and decentration and associated factors in age-related cataract.

PURPOSE: To investigate the characteristics and factors associated with crystalline lens tilt and decentration measured by CASIA2 anterior segment optical coherence tomography. SETTING: Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China. DESIGN: Cross-sectional study. METHODS: 1097 eyes of 1097 patients who planned to undergo cataract surgery were enrolled. All patients underwent a general ophthalmologic examination. Lens thickness (LT), front curvature radius (FCR), back curvature radius, lens equator diameter (LED), tilt, and decentration of preoperative crystalline lenses were measured by CASIA2. Univariate and multivariate regression analyses were performed to evaluate the relationships between the tilt and decentration of crystalline lens with related factors. RESULTS: The natural crystalline lenses showed a mean tilt of 5.16 degrees toward the inferotemporal direction and a mean decentration of 0.22 mm toward the temporal direction. Of the total 1097 eyes, 119 eyes (10.85%) had a tilt greater than 7 degrees, and 89 eyes (8.11%) had a decentration more than 0.4 mm. Multivariate regression analysis showed that larger decentration, thicker LT, shorter axial length (AL), and FCR were associated with greater lens tilt (P < .001, P = .007, P = .006, and P = .003, respectively). In addition, greater tilt, older and thinner LT were correlated with larger decentration (all P < .001). CONCLUSIONS: Preoperative crystalline lens had a certain degree of tilt and decentration in age-related cataract. The greater tilt of the crystalline lens was, the larger decentration of it was. In addition, AL, FCR, LT, and age also correlated with tilt and decentration.

Characteristics and factors associated with intraocular lens tilt and decentration after cataract surgery.

PURPOSE: To analyze the characteristics and factors associated with intraocular lens (IOL) tilt and decentration after uneventful phacoemulsification with IOL implantation. SETTING: Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China. DESIGN: Cross-sectional study. METHODS: All patients underwent a general ophthalmologic examination and anterior segment photography. IOL tilt and decentration were measured with a second-generation anterior segment optical coherence tomography (Casia2). Univariate and multivariate regression analyses were performed to assess the association between IOL tilt and decentration with ocular biometric and systemic parameters, and the visual acuity. RESULTS: A total of 196 eyes of 196 patients were enrolled in this study. IOLs showed a mean tilt of 4.8 degrees toward the inferotemporal direction, and the mean decentration was 0.21 mm. Both eyes presented a mirror symmetry relationship. Twenty-two eyes (11.22%) had a tilt greater than 7 degrees, and 21 eyes (10.72%) had a decentration more than 0.4 mm. Multivariate regression analysis showed previous pars plana vitrectomy (PPV) and short axial length (AL) were associated with greater IOL tilt (P = .014 and P < .001). In addition, long AL, thicker lens, and less capsulorhexis-IOL overlap were positively correlated with decentration (P < .001, P = .029, and P = .026). Corrected distance visual acuity did not directly correlate with IOL tilt and decentration (P = .417 and P = .550). CONCLUSIONS: PPV history and short AL were associated with greater IOL tilt, whereas longer AL, thicker lens, and overlarge capsulorhexis contribute to greater decentration. Implantation of toric and multifocal IOLs in these patients should be cautious.

The lived experiences of patients undergoing acellular porcine corneal stroma transplantation.

To explore the lived experiences of patients undergoing acellular porcine corneal stroma (APCS) transplantation, a descriptive, qualitative design was performed. A purposive sample of 13 patients who underwent APCS transplantation to treat progressive infectious keratitis were enrolled in the semi-structured, open-ended interviews. The taped and transcribed interviews were analyzed using a thematic analysis approach. Alterations in the transparency of APCS grafts were accompanied by a gradual improved visual acuity (before surgery: 1.38± 0.91 logMAR; 3mo postoperatively: 0.40±0.24 logMAR, respectively). Accordingly, in terms of lived experiences, the patients generally reported "negative" experiences before the operation and during the early postoperative period, but this was greatly improved 3mo after surgery. Four main themes were derived: anxiety and fear, stigma, lifestyle change, and gratitude and insights. Conclusively, health care professionals should provide holistic care for patients, proactively promoting patients' physical and mental health.