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1. Italian translation and validation of the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)

Author

Zeri, F, Tavazzi, S, Naroo, S, Recchioni, A, Menduni, F, Ponzini, E, Chalmers, R, Desiato, A, Zeri, Fabrizio, Tavazzi, Silvia, Naroo, Shehzad A, Recchioni, Alberto, Menduni, Francesco, Ponzini, Erika, Chalmers, Robin, Desiato, Alfredo, Zeri, F, Tavazzi, S, Naroo, S, Recchioni, A, Menduni, F, Ponzini, E, Chalmers, R, Desiato, A, Zeri, Fabrizio, Tavazzi, Silvia, Naroo, Shehzad A, Recchioni, Alberto, Menduni, Francesco, Ponzini, Erika, Chalmers, Robin, and Desiato, Alfredo

Abstract

Purpose: To translate and validate an Italian version of the CLDEQ-8 (CLDEQ-8_IT). Methods: The study was carried out in two phases. In the first phase, a cross-cultural adaptation of CLDEQ-8 to Italian was performed by forward and backward translation in sequence. In the second phase, a multi-centre study was conducted for the validation of the questionnaire. Validity CLDEQ-8_IT was evaluated against three gestalt questions: overall opinion of soft contact lenses (CLs), global self-assessments of eye sensitivity and eye dryness. Reliability was evaluated by test–retest assessment in a subgroup of subjects. Finally, the psychometric properties of CLDEQ-8_IT were explored by Rasch analysis. Results: Two hundred and forty soft CL wearers, fluent Italian speakers (73 males and 167 females), between 18 and 70 years of age were enrolled. A significant correlation was found between CLDEQ-8_IT and each of the three Gestalt questions. The cutoff score of 12 points demonstrated the best balance between sensitivity and specificity in differentiating wearers grading their CLs as “Excellent/Very good” from those reporting their overall opinion as “Good/Fair/Poor”. The Intraclass Correlation Coefficient between test and retest was 0.88 (95% CI: 0.81–0.92). Finally, infit and outfit statistics using Rasch analysis for the 8 items were in a good range, however Principal Components Analysis revealed a certain degree of multi-dimensionality of the instrument. Also, item 8 analysis could be computed after merging the last two response categories. Conclusion: The CLDEQ-8_IT showed very good validity and reliability in measuring symptoms of CL wearers, comparable to the original English language version. A cut-off of 12 was confirmed as yielding the best balance between sensitivity and specificity in detecting CL wearers who could benefit from clinical management of their CL-related symptoms. Collapsing of the response options 5 and 6 in the last item of questionnaire could optimise it

Published
2023

5. Embryology

Author

Gandhi, G., primary, Allahbadia, G., additional, Kagalwala, S., additional, Allahbadia, A., additional, Ramesh, S., additional, Patel, K., additional, Hinduja, R., additional, Chipkar, V., additional, Madne, M., additional, Ramani, R., additional, Joo, J. K., additional, Jeung, J. E., additional, Go, K. R., additional, Lee, K. S., additional, Goto, H., additional, Hashimoto, S., additional, Amo, A., additional, Yamochi, T., additional, Iwata, H., additional, Morimoto, Y., additional, Koifman, M., additional, Lahav-Baratz, S., additional, Blais, E., additional, Megnazi-Wiener, Z., additional, Ishai, D., additional, Auslender, R., additional, Dirnfeld, M., additional, Zaletova, V., additional, Zakharova, E., additional, Krivokharchenko, I., additional, Zaletov, S., additional, Zhu, L., additional, Li, Y., additional, Zhang, H., additional, Ai, J., additional, Jin, L., additional, Zhang, X., additional, Rajan, N., additional, Kovacs, A., additional, Foley, C., additional, Flanagan, J., additional, O'Callaghan, J., additional, Waterstone, J., additional, Dineen, T., additional, Dahdouh, E. M., additional, St-Michel, P., additional, Granger, L., additional, Carranza-Mamane, B., additional, Faruqi, F., additional, Kattygnarath, T. V., additional, Gomes, F. L. A. F., additional, Christoforidis, N., additional, Ioakimidou, C., additional, Papas, C., additional, Moisidou, M., additional, Chatziparasidou, A., additional, Klaver, M., additional, Tilleman, K., additional, De Sutter, P., additional, Lammers, J., additional, Freour, T., additional, Splingart, C., additional, Barriere, P., additional, Ikeno, T., additional, Nakajyo, Y., additional, Sato, Y., additional, Hirata, K., additional, Kyoya, T., additional, Kyono, K., additional, Campos, F. B., additional, Meseguer, M., additional, Nogales, M., additional, Martinez, E., additional, Ariza, M., additional, Agudo, D., additional, Rodrigo, L., additional, Garcia-Velasco, J. A., additional, Lopes, A. S., additional, Frederickx, V., additional, Vankerkhoven, G., additional, Serneels, A., additional, Roziers, P., additional, Puttermans, P., additional, Campo, R., additional, Gordts, S., additional, Fragouli, E., additional, Alfarawati, S., additional, Spath, K., additional, Wells, D., additional, Liss, J., additional, Lukaszuk, K., additional, Glowacka, J., additional, Bruszczynska, A., additional, Gallego, S. C., additional, Lopez, L. O., additional, Vila, E. O., additional, Garcia, M. G., additional, Canas, C. L., additional, Segovia, A. G., additional, Ponce, A. G., additional, Calonge, R. N., additional, Peregrin, P. C., additional, Ito, K., additional, Nakaoka, Y., additional, Alcoba, D. D., additional, Valerio, E. G., additional, Conzatti, M., additional, Tornquist, J., additional, Kussler, A. P., additional, Pimentel, A. M., additional, Corleta, H. E., additional, Brum, I. S., additional, Boyer, P., additional, Montjean, D., additional, Tourame, P., additional, Gervoise-Boyer, M., additional, Cohen, J., additional, Lefevre, B., additional, Radio, C. I., additional, Wolf, J. P., additional, Ziyyat, A., additional, De Croo, I., additional, Tolpe, A., additional, Degheselle, S., additional, Van de Velde, A., additional, Van den Abbeel, E., additional, Gandhi, G., additional, Kuwayama, M., additional, Khatoon, A., additional, Alsule, S., additional, Inaba, M., additional, Ohgaki, A., additional, Ohtani, A., additional, Matsumoto, H., additional, Mizuno, S., additional, Mori, R., additional, Fukuda, A., additional, Umekawa, Y., additional, Yoshida, A., additional, Tanigiwa, S., additional, Seida, K., additional, Suzuki, H., additional, Tanaka, M., additional, Vahabi, Z., additional, Yazdi, P. E., additional, Dalman, A., additional, Ebrahimi, B., additional, Mostafaei, F., additional, Niknam, M. R., additional, Watanabe, S., additional, Kamihata, M., additional, Tanaka, T., additional, Matsunaga, R., additional, Yamanaka, N., additional, Kani, C., additional, Ishikawa, T., additional, Wada, T., additional, Morita, H., additional, Miyamura, H., additional, Nishio, E., additional, Ito, M., additional, Kuwahata, A., additional, Ochi, M., additional, Horiuchi, T., additional, Dal Canto, M., additional, Guglielmo, M. C., additional, Fadini, R., additional, Renzini, M. M., additional, Albertini, D. F., additional, Novara, P., additional, Lain, M., additional, Brambillasca, F., additional, Turchi, D., additional, Sottocornola, M., additional, Coticchio, G., additional, Kato, M., additional, Fukunaga, N., additional, Nagai, R., additional, Kitasaka, H., additional, Yoshimura, T., additional, Tamura, F., additional, Hasegawa, N., additional, Nakayama, K., additional, Takeuchi, M., additional, Ohno, H., additional, Aoyagi, N., additional, Kojima, E., additional, Itoi, F., additional, Hashiba, Y., additional, Asada, Y., additional, Kikuchi, H., additional, Iwasa, Y., additional, Kamono, T., additional, Suzuki, A., additional, Yamada, K., additional, Kanno, H., additional, Sasaki, K., additional, Murakawa, H., additional, Matsubara, M., additional, Yoshida, H., additional, Valdespin, C., additional, Elhelaly, M., additional, Chen, P., additional, Pangestu, M., additional, Catt, S., additional, Hojnik, N., additional, Kovacic, B., additional, Roglic, P., additional, Taborin, M., additional, Zafosnik, M., additional, Knez, J., additional, Vlaisavljevic, V., additional, Mori, C., additional, Yabuuchi, A., additional, Ezoe, K., additional, Takayama, Y., additional, Aono, F., additional, Kato, K., additional, Radwan, P., additional, Krasinski, R., additional, Chorobik, K., additional, Radwan, M., additional, Stoppa, M., additional, Maggiulli, R., additional, Capalbo, A., additional, Ievoli, E., additional, Dovere, L., additional, Scarica, C., additional, Albricci, L., additional, Romano, S., additional, Sanges, F., additional, Barnocchi, N., additional, Papini, L., additional, Vivarelli, A., additional, Ubaldi, F. M., additional, Rienzi, L., additional, Bono, S., additional, Spizzichino, L., additional, Rubio, C., additional, Fiorentino, F., additional, Ferris, J., additional, Favetta, L. A., additional, MacLusky, N., additional, King, W. A., additional, Madani, T., additional, Jahangiri, N., additional, Aflatoonian, R., additional, Cater, E., additional, Hulme, D., additional, Berrisford, K., additional, Jenner, L., additional, Campbell, A., additional, Fishel, S., additional, Zhang, X. Y., additional, Yilmaz, A., additional, Hananel, H., additional, Ao, A., additional, Vutyavanich, T., additional, Piromlertamorn, W., additional, Saenganan, U., additional, Samchimchom, S., additional, Wirleitner, B., additional, Lejeune, B., additional, Zech, N. H., additional, Vanderzwalmen, P., additional, Albani, E., additional, Parini, V., additional, Smeraldi, A., additional, Menduni, F., additional, Antonacci, R., additional, Marras, A., additional, Levi, S., additional, Morreale, G., additional, Pisano, B., additional, Di Biase, A., additional, Di Rosa, A., additional, Setti, P. E. L., additional, Puard, V., additional, Cadoret, V., additional, Tranchant, T., additional, Gauthier, C., additional, Reiter, E., additional, Guerif, F., additional, Royere, D., additional, Yoon, S. Y., additional, Eum, J. H., additional, Park, E. A., additional, Kim, T. Y., additional, Yoon, T. K., additional, Lee, D. R., additional, Lee, W. S., additional, Cabal, A. C., additional, Vallejo, B., additional, Campos, P., additional, Sanchez, E., additional, Serrano, J., additional, Remohi, J., additional, Nagornyy, V., additional, Mazur, P., additional, Mykytenko, D., additional, Semeniuk, L., additional, Zukin, V., additional, Guilherme, P., additional, Madaschi, C., additional, Bonetti, T. C. S., additional, Fassolas, G., additional, Izzo, C. R., additional, Santos, M. J. D. L., additional, Beltran, D., additional, Garcia-Laez, V., additional, Escriba, M. J., additional, Grau, N., additional, Escrich, L., additional, Albert, C., additional, Zuzuarregui, J. L., additional, Pellicer, A., additional, LU, Y., additional, Nikiforaki, D., additional, Meerschaut, F. V., additional, Neupane, J., additional, De Vos, W. H., additional, Lierman, S., additional, Deroo, T., additional, Heindryckx, B., additional, Li, J., additional, Chen, X. Y., additional, Lin, G., additional, Huang, G. N., additional, Sun, Z. Y., additional, Zhong, Y., additional, Zhang, B., additional, Li, T., additional, Zhang, S. P., additional, Ye, H., additional, Han, S. B., additional, Liu, S. Y., additional, Zhou, J., additional, Lu, G. X., additional, Zhuang, G. L., additional, Muela, L., additional, Roldan, M., additional, Gadea, B., additional, Martinez, M., additional, Perez, I., additional, Munoz, M., additional, Castello, C., additional, Asensio, M., additional, Fernandez, P., additional, Farreras, A., additional, Rovira, S., additional, Capdevila, J. M., additional, Velilla, E., additional, Lopez-Teijon, M., additional, Kovacs, P., additional, Matyas, S. Z., additional, Forgacs, V., additional, Reichart, A., additional, Rarosi, F., additional, Bernard, A., additional, Torok, A., additional, Kaali, S. G., additional, Sajgo, A., additional, Pribenszky, C. S., additional, Sozen, B., additional, Ozturk, S., additional, Yaba-Ucar, A., additional, Demir, N., additional, Gelo, N., additional, Stanic, P., additional, Hlavati, V., additional, ogoric, S., additional, Pavicic-Baldani, D., additional, prem-Goldtajn, M., additional, Radakovic, B., additional, Kasum, M., additional, Strelec, M., additional, Canic, T., additional, imunic, V., additional, Vrcic, H., additional, Ajina, M., additional, Negra, D., additional, Ben-Ali, H., additional, Jallad, S., additional, Zidi, I., additional, Meddeb, S., additional, Bibi, M., additional, Khairi, H., additional, Saad, A., additional, Gamiz, P., additional, Viloria, T., additional, Lima, E. T., additional, Fernandez, M. P., additional, Prieto, J. A. A., additional, Varela, M. O., additional, Kassa, D., additional, Munoz, E. M., additional, Kani, K., additional, Nor-Ashikin, M. N. K., additional, Norhazlin, J. M. Y., additional, Norita, S., additional, Wan-Hafizah, W. J., additional, Mohd-Fazirul, M., additional, Razif, D., additional, Hoh, B. P., additional, Dale, S., additional, Woodhead, G., additional, Andronikou, S., additional, Francis, G., additional, Tailor, S., additional, Vourliotis, M., additional, Almeida, P. A., additional, Krivega, M., additional, Van de Velde, H., additional, Lee, R. K., additional, Hwu, Y. M., additional, Lu, C. H., additional, Li, S. H., additional, Vaiarelli, A., additional, Desgro, M., additional, Baggiani, A., additional, Zannoni, E., additional, Kermavner, L. B., additional, Klun, I. V., additional, Pinter, B., additional, Vrtacnik-Bokal, E., additional, De Paepe, C., additional, Cauffman, G., additional, Verheyen, G., additional, Stoop, D., additional, Liebaers, I., additional, Stecher, A., additional, Zintz, M., additional, Neyer, A., additional, Bach, M., additional, Baramsai, B., additional, Schwerda, D., additional, Wiener-Megnazi, Z., additional, Fridman, M., additional, Blais, I., additional, Akerud, H., additional, Lindgren, K., additional, Karehed, K., additional, Wanggren, K., additional, Hreinsson, J., additional, Freijomil, B., additional, Weiss, A., additional, Neril, R., additional, Geslevich, J., additional, Beck-Fruchter, R., additional, Lavee, M., additional, Golan, J., additional, Ermoshkin, A., additional, Shalev, E., additional, Shi, W., additional, Zhang, S., additional, Zhao, W., additional, Xue, X. I. A., additional, Wang, M. I. N., additional, Bai, H., additional, Shi, J., additional, Smith, H. L., additional, Shaw, L., additional, Kimber, S., additional, Brison, D., additional, Boumela, I., additional, Assou, S., additional, Haouzi, D., additional, Ahmed, O. A., additional, Dechaud, H., additional, Hamamah, S., additional, Dasiman, R., additional, Nor-Shahida, A. R., additional, Salina, O., additional, Gabriele, R. A. F., additional, Ben-Yosef, D., additional, Shwartz, T., additional, Cohen, T., additional, Carmon, A., additional, Raz, N. M., additional, Malcov, M., additional, Frumkin, T., additional, Almog, B., additional, Vagman, I., additional, Kapustiansky, R., additional, Reches, A., additional, Azem, F., additional, Amit, A., additional, Cetinkaya, M., additional, Pirkevi, C., additional, Yelke, H., additional, Kumtepe, Y., additional, Atayurt, Z., additional, Kahraman, S., additional, Risco, R., additional, Hebles, M., additional, Saa, A. M., additional, Vilches-Ferron, M. A., additional, Sanchez-Martin, P., additional, Lucena, E., additional, Lucena, M., additional, Heras, M. D. L., additional, Agirregoikoa, J. A., additional, Barrenetxea, G., additional, De Pablo, J. L., additional, Lehner, A., additional, Pribenszky, C., additional, Murber, A., additional, Rigo, J., additional, Urbancsek, J., additional, Fancsovits, P., additional, Bano, D. G., additional, Sanchez-Leon, A., additional, Marcos, J., additional, Molla, M., additional, Amorocho, B., additional, Nicolas, M., additional, Fernandez, L., additional, Landeras, J., additional, Adeniyi, O. A., additional, Ehbish, S. M., additional, Brison, D. R., additional, Egashira, A., additional, Murakami, M., additional, Nagafuchi, E., additional, Tanaka, K., additional, Tomohara, A., additional, Mine, C., additional, Otsubo, H., additional, Nakashima, A., additional, Otsuka, M., additional, Yoshioka, N., additional, Kuramoto, T., additional, Choi, D., additional, Yang, H., additional, Park, J. H., additional, Jung, J. H., additional, Hwang, H. G., additional, Lee, J. H., additional, Lee, J. E., additional, Kang, A. S., additional, Yoo, J. H., additional, Kwon, H. C., additional, Lee, S. J., additional, Bang, S., additional, Shin, H., additional, Lim, H. J., additional, Min, S. H., additional, Yeon, J. Y., additional, Koo, D. B., additional, Higo, S., additional, Ruvalcaba, L., additional, Kobayashi, M., additional, Takeuchi, T., additional, Miwa, A., additional, Nagai, Y., additional, Momma, Y., additional, Takahashi, K., additional, Chuko, M., additional, Nagai, A., additional, Otsuki, J., additional, Kim, S. G., additional, Kim, Y. Y., additional, Kim, H. J., additional, Park, I. H., additional, Sun, H. G., additional, Lee, K. H., additional, Song, H. J., additional, Costa-Borges, N., additional, Belles, M., additional, Herreros, J., additional, Teruel, J., additional, Ballesteros, A., additional, Calderon, G., additional, Vossaert, L., additional, Qian, C., additional, Lu, Y., additional, Parys, J. B., additional, Deforce, D., additional, Leybaert, L., additional, Surlan, L., additional, Otasevic, V., additional, Velickovic, K., additional, Golic, I., additional, Vucetic, M., additional, Stankovic, V., additional, Stojnic, J., additional, Radunovic, N., additional, Tulic, I., additional, Korac, B., additional, Korac, A., additional, Elias, R., additional, Neri, Q. V., additional, Fields, T., additional, Schlegel, P. N., additional, Rosenwaks, Z., additional, Palermo, G. D., additional, Gilson, A., additional, Piront, N., additional, Heens, B., additional, Vastersaegher, C., additional, Vansteenbrugge, A., additional, Pauwels, P. C. P., additional, Abdel-Raheem, M. F., additional, Abdel-Rahman, M. Y., additional, Abdel-Gaffar, H. M., additional, Sabry, M., additional, Kasem, H., additional, Rasheed, S. M., additional, Amin, M., additional, Abdelmonem, A., additional, Ait-Allah, A. S., additional, VerMilyea, M., additional, Anthony, J., additional, Bucci, J., additional, Croly, S., additional, Coutifaris, C., additional, Cimadomo, D., additional, Dusi, L., additional, Colamaria, S., additional, Baroni, E., additional, Giuliani, M., additional, Sapienza, F., additional, Buffo, L., additional, Zivi, E., additional, Aizenman, E., additional, Barash, D., additional, Gibson, D., additional, Shufaro, Y., additional, Perez, M., additional, Aguilar, J., additional, Taboas, E., additional, Ojeda, M., additional, Suarez, L., additional, Munoz, E., additional, Casciani, V., additional, Minasi, M. G., additional, Scarselli, F., additional, Terribile, M., additional, Zavaglia, D., additional, Colasante, A., additional, Franco, G., additional, Greco, E., additional, Hickman, C., additional, Cook, C., additional, Gwinnett, D., additional, Trew, G., additional, Carby, A., additional, Lavery, S., additional, Asgari, L., additional, Paouneskou, D., additional, Jayaprakasan, K., additional, Maalouf, W., additional, Campbell, B. K., additional, Rega, E., additional, Alteri, A., additional, Cotarelo, R. P., additional, Rubino, P., additional, Colicchia, A., additional, Giannini, P., additional, Devjak, R., additional, Papler, T. B., additional, Tacer, K. F., additional, Verdenik, I., additional, Iussig, B., additional, Gala, A., additional, Ferrieres, A., additional, Vincens, C., additional, Bringer-Deutsch, S., additional, Brunet, C., additional, Conaghan, J., additional, Tan, L., additional, Gvakharia, M., additional, Ivani, K., additional, Chen, A., additional, Pera, R. R., additional, Bowman, N., additional, Montgomery, S., additional, Best, L., additional, Duffy, S., additional, Hirata, R., additional, Aoi, Y., additional, Habara, T., additional, Hayashi, N., additional, Dinopoulou, V., additional, Partsinevelos, G. A., additional, Bletsa, R., additional, Mavrogianni, D., additional, Anagnostou, E., additional, Stefanidis, K., additional, Drakakis, P., additional, Loutradis, D., additional, Hernandez, J., additional, Leon, C. L., additional, Puopolo, M., additional, Palumbo, A., additional, Atig, F., additional, Kerkeni, A., additional, D'Ommar, G., additional, Herrera, A. K., additional, Lozano, L., additional, Majerfeld, M., additional, Ye, Z., additional, Zaninovic, N., additional, Clarke, R., additional, Bodine, R., additional, Nagorny, V., additional, Zabala, A., additional, Pessino, T., additional, Outeda, S., additional, Blanco, L., additional, Leocata, F., additional, Asch, R., additional, Rajikin, M. H., additional, Nuraliza, A. S., additional, Machac, S., additional, Hubinka, V., additional, Larman, M., additional, Koudelka, M., additional, Budak, T. P., additional, Membrado, O. O., additional, Martinez, E. S., additional, Wilson, P., additional, McClure, A., additional, Nargund, G., additional, Raso, D., additional, Insua, M. F., additional, Lotti, B., additional, Giordana, S., additional, Baldi, C., additional, Barattini, J., additional, Cogorno, M., additional, Peri, N. F., additional, Neuspiller, F., additional, Resta, S., additional, Filannino, A., additional, Maggi, E., additional, Cafueri, G., additional, Ferraretti, A. P., additional, Magli, M. C., additional, Gianaroli, L., additional, Sioga, A., additional, Oikonomou, Z., additional, Chatzimeletiou, K., additional, Oikonomou, L., additional, Kolibianakis, E., additional, Tarlatzis, B. C., additional, Sarkar, M. R., additional, Ray, D., additional, Bhattacharya, J., additional, Alises, J. M., additional, Gumbao, D., additional, Hickman, C. F. L., additional, Fiorentino, I., additional, Gualtieri, R., additional, Barbato, V., additional, Braun, S., additional, Mollo, V., additional, Netti, P., additional, Talevi, R., additional, Bayram, A., additional, Findikli, N., additional, Serdarogullari, M., additional, Sahin, O., additional, Ulug, U., additional, Tosun, S. B., additional, Bahceci, M., additional, Leon, A. S., additional, Cardoso, M. C. A., additional, Aguiar, A. P. S., additional, Sartorio, C., additional, Evangelista, A., additional, Gallo-Sa, P., additional, Erthal-Martins, M. C., additional, Mantikou, E., additional, Jonker, M. J., additional, de Jong, M., additional, Wong, K. M., additional, van Montfoort, A. P. A., additional, Breit, T. M., additional, Repping, S., additional, Mastenbroek, S., additional, Power, E., additional, Jordan, K., additional, Aksoy, T., additional, Gultomruk, M., additional, Aktan, A., additional, Goktas, C., additional, Petracco, R., additional, Okada, L., additional, Azambuja, R., additional, Badalotti, F., additional, Michelon, J., additional, Reig, V., additional, Kvitko, D., additional, Tagliani-Ribeiro, A., additional, Badalotti, M., additional, Petracco, A., additional, Aydin, B., additional, Cepni, I., additional, Rodriguez-Arnedo, D., additional, Ten, J., additional, Guerrero, J., additional, Ochando, I., additional, and Bernabeu, R., additional

Published
2013
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9. Italian translation and validation of the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)

Author

Fabrizio Zeri, Silvia Tavazzi, Shehzad A. Naroo, Alberto Recchioni, Francesco Menduni, Erika Ponzini, Robin Chalmers, Alfredo Desiato, Zeri, F, Tavazzi, S, Naroo, S, Recchioni, A, Menduni, F, Ponzini, E, Chalmers, R, and Desiato, A

Subjects
Ophthalmology, CLDEQ-8_IT, Contact lens discomfort, Questionnaire, Symptom, General Medicine, Optometry
Abstract

Purpose: To translate and validate an Italian version of the CLDEQ-8 (CLDEQ-8_IT). Methods: The study was carried out in two phases. In the first phase, a cross-cultural adaptation of CLDEQ-8 to Italian was performed by forward and backward translation in sequence. In the second phase, a multi-centre study was conducted for the validation of the questionnaire. Validity CLDEQ-8_IT was evaluated against three gestalt questions: overall opinion of soft contact lenses (CLs), global self-assessments of eye sensitivity and eye dryness. Reliability was evaluated by test–retest assessment in a subgroup of subjects. Finally, the psychometric properties of CLDEQ-8_IT were explored by Rasch analysis. Results: Two hundred and forty soft CL wearers, fluent Italian speakers (73 males and 167 females), between 18 and 70 years of age were enrolled. A significant correlation was found between CLDEQ-8_IT and each of the three Gestalt questions. The cutoff score of 12 points demonstrated the best balance between sensitivity and specificity in differentiating wearers grading their CLs as “Excellent/Very good” from those reporting their overall opinion as “Good/Fair/Poor”. The Intraclass Correlation Coefficient between test and retest was 0.88 (95% CI: 0.81–0.92). Finally, infit and outfit statistics using Rasch analysis for the 8 items were in a good range, however Principal Components Analysis revealed a certain degree of multi-dimensionality of the instrument. Also, item 8 analysis could be computed after merging the last two response categories. Conclusion: The CLDEQ-8_IT showed very good validity and reliability in measuring symptoms of CL wearers, comparable to the original English language version. A cut-off of 12 was confirmed as yielding the best balance between sensitivity and specificity in detecting CL wearers who could benefit from clinical management of their CL-related symptoms. Collapsing of the response options 5 and 6 in the last item of questionnaire could optimise its functioning.

Published
2023

10. Italian translation and validation of the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8).

Author

Zeri F, Tavazzi S, Naroo SA, Recchioni A, Menduni F, Ponzini E, Chalmers R, and Desiato A

Subjects
Male, Female, Humans, Reproducibility of Results, Surveys and Questionnaires, Language, Dry Eye Syndromes diagnosis, Dry Eye Syndromes etiology, Contact Lenses, Hydrophilic
Abstract

Purpose: To translate and validate an Italian version of the CLDEQ-8 (CLDEQ-8_IT)., Methods: The study was carried out in two phases. In the first phase, a cross-cultural adaptation of CLDEQ-8 to Italian was performed by forward and backward translation in sequence. In the second phase, a multi-centre study was conducted for the validation of the questionnaire. Validity CLDEQ-8_IT was evaluated against three gestalt questions: overall opinion of soft contact lenses (CLs), global self-assessments of eye sensitivity and eye dryness. Reliability was evaluated by test-retest assessment in a subgroup of subjects. Finally, the psychometric properties of CLDEQ-8_IT were explored by Rasch analysis., Results: Two hundred and forty soft CL wearers, fluent Italian speakers (73 males and 167 females), between 18 and 70 years of age were enrolled. A significant correlation was found between CLDEQ-8_IT and each of the three Gestalt questions. The cutoff score of 12 points demonstrated the best balance between sensitivity and specificity in differentiating wearers grading their CLs as "Excellent/Very good" from those reporting their overall opinion as "Good/Fair/Poor". The Intraclass Correlation Coefficient between test and retest was 0.88 (95% CI: 0.81-0.92). Finally, infit and outfit statistics using Rasch analysis for the 8 items were in a good range, however Principal Components Analysis revealed a certain degree of multi-dimensionality of the instrument. Also, item 8 analysis could be computed after merging the last two response categories., Conclusion: The CLDEQ-8_IT showed very good validity and reliability in measuring symptoms of CL wearers, comparable to the original English language version. A cut-off of 12 was confirmed as yielding the best balance between sensitivity and specificity in detecting CL wearers who could benefit from clinical management of their CL-related symptoms. Collapsing of the response options 5 and 6 in the last item of questionnaire could optimise its functioning., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier Ltd.)

Published
2023
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13. Demographic and lifestyle risk factors of dry eye disease subtypes: A cross-sectional study.

Author

Wolffsohn JS, Wang MTM, Vidal-Rohr M, Menduni F, Dhallu S, Ipek T, Acar D, Recchioni A, France A, Kingsnorth A, and Craig JP

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Cross-Sectional Studies, Demography, Female, Humans, Life Style, Middle Aged, Risk Factors, Tears, Young Adult, Dry Eye Syndromes epidemiology, Meibomian Glands
Abstract

Purpose: To evaluate demographic and lifestyle factors associated with aqueous deficient and evaporative dry eye disease., Methods: A total of 1125 general public visitors (707 females, mean ± SD age, 33 ± 21, range 5-90 years) at the Royal Society Summer Science Exhibition were recruited in a cross-sectional study. A demographic and lifestyle factor questionnaire was administered, and dry eye symptomology (DEQ-5 score), ocular surface characteristics (conjunctival hyperaemia, and infrared meibography), and tear film parameters (tear meniscus height, non-invasive breakup time, and lipid layer grade) were evaluated for the left eye of each participant within a single session. The diagnostic criteria for dry eye disease subtypes were adapted from the rapid non-invasive dry eye assessment algorithm., Results: Overall, 428 (38%) participants fulfilled the diagnostic criteria for dry eye disease, 161 (14%) with aqueous deficient dry eye disease, and 339 (30%) with evaporative dry eye disease. Multivariate logistic regression demonstrated that advancing age, female sex, reduced sleep duration, higher psychological stress, and poorer self-perceived health status were independently associated with aqueous deficient dry eye disease (all p < 0.05). Significant risk factors for evaporative dry eye disease included advancing age, East and South Asian ethnicity, contact lens wear, increased digital device screen exposure, higher psychological stress, and poorer self-perceived health status (all p < 0.05)., Conclusions: Both subtypes of dry eye disease were associated with several unique and shared demographic and lifestyle factors. The findings of this study could inform future research design investigating the utility of targeted screening and risk factor modification for the prevention and management of dry eye disease., (Copyright © 2021. Published by Elsevier Inc.)

Published
2021
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14. Characterisation of the porcine eyeball as an in-vitro model for dry eye.

Author

Menduni F, Davies LN, Madrid-Costa D, Fratini A, and Wolffsohn JS

Subjects
Animals, Disease Models, Animal, Organ Size, Swine, Anterior Chamber pathology, Corneal Pachymetry methods, Corneal Topography methods, Dry Eye Syndromes diagnostic imaging, Tomography, Optical Coherence methods
Abstract

Purpose: To characterise the anatomical parameters of the porcine eye for potentially using it as a laboratory model of dry eye., Methods: Anterior chamber depth and angle, corneal curvature, shortest and longest diameter, endothelial cell density, and pachymetry were measured in sixty freshly enucleated porcine eyeballs., Results: Corneal steepest meridian was 7.85±0.32mm, corneal flattest meridian was 8.28±0.32mm, shortest corneal diameter was 12.69±0.58mm, longest corneal diameter was 14.88±0.66mm and central corneal ultrasonic pachymetry was 1009±1μm. Anterior chamber angle was 28.83±4.16°, anterior chamber depth was 1.77±0.27mm, and central corneal thickness measured using OCT was 1248±144μm. Corneal endothelial cell density was 3250±172 cells/mm 2 ., Conclusions: Combining different clinical techniques produced a pool of reproducible data on the porcine eye anatomy, which can be used by researchers to assess the viability of using the porcine eye as an in-vitro/ex-vivo model for dry eye. Due to the similar morphology with the human eye, porcine eyeballs may represent a useful and cost effective model to individually study important key factors in the development of dry eye, such as environmental and mechanical stresses., (Copyright © 2017 British Contact Lens Association. Published by Elsevier Ltd. All rights reserved.)

Published
2018
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15. New methods for cooling and storing oocytes and embryos in a clean environment of -196°C.

Author

Arav A, Natan Y, Levi-Setti PE, Menduni F, and Patrizio P

Subjects
Animals, Blastocyst cytology, Cold Temperature, Female, Fertilization in Vitro, Humans, Mice, Mice, Inbred C57BL, Mice, Inbred CBA, Oocytes cytology, Oxygen chemistry, Vitrification, Cryopreservation methods, Cryoprotective Agents therapeutic use, Embryo Culture Techniques methods, Embryo Transfer methods
Abstract

It is well documented that oocyte vitrification using open systems provides better results than closed systems. However, its use is limited owing to risks of contamination posed by direct exposure to liquid nitrogen and cross-contamination when stored in liquid nitrogen tanks. A device that produces clean liquid air (CLAir) having similar a temperature as liquid nitrogen and a sterile storage canister device (Esther) that keeps samples sealed in their own compartment while in regular liquid nitrogen tanks were developed. The following experiments were performed: temperature measurements, bioburden tests, vitrification and storage experiments with mice embryos and human oocytes. Results showed similar cooling rates for liquid nitrogen and liquid air. Bioburden tests of CLAir and Esther showed no contamination, while massive contamination was found in "commercial" liquid nitrogen and storage canisters. Mice blastocysts had a survival rate of over 90%, with 80% hatching rate after vitirification in CLAir and 1 week storage in Esther, similar to the fresh (control) results. Human oocytes vitrified in CLAir and in liquid nitrogen for three consecutive vitrification/warming cycles showed 100% survival, seen as re-expansion in both groups. These new systems represent a breakthrough for safe vitrification using open systems and a safe storage process generally., (Copyright © 2016 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

Published
2016
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16. Obstetric outcome and incidence of congenital anomalies in 2351 IVF/ICSI babies.

Author

Levi Setti PE, Moioli M, Smeraldi A, Cesaratto E, Menduni F, Livio S, Morenghi E, and Patrizio P

Subjects
Adult, Female, Humans, Incidence, Infertility complications, Male, Pregnancy, Pregnancy Outcome, Pregnancy, Multiple, Retrospective Studies, Congenital Abnormalities epidemiology, Embryo Transfer adverse effects, Fertilization in Vitro adverse effects
Abstract

Purpose: The aim of this study was to provide a comprehensive follow-up of fetal and perinatal outcome and the incidence of congenital anomalies in babies born after fresh embryo transfers compared to those conceived spontaneously in infertile couples., Methods: Retrospective comparative analysis of all clinical pregnancies from fresh cleavage-stage embryo transfer cycles (IVF and ICSI) compared with infertile patients who conceived spontaneously in the same time period (control). Congenital anomalies were classified following the European Surveillance of Congenital Anomalies (EUROCAT) classification., Results: A total of 2414 assisted reproductive technology (ART) pregnancies were compared to 582 spontaneous conceptions in the control infertile group representing 2306 deliveries. No significant differences were found in pregnancy outcome between the two groups (delivery rate, abortion rate, ectopic pregnancies, medical abortions for fetal anomalies, single and twins mean gestational age, and weight at delivery). A significant difference (p < 0.001) was found in the twin (21.3 vs 2.3 %) and triplet rates (2.3 vs 0 %). A total of 2351 babies were delivered in the ART group and 449 in the control group. A total of 90 babies (3.8 %) were diagnosed with a major congenital anomaly in the ART group and 15 (3.3 %) in the control group (p = ns). The overall rate of major congenital anomalies (105/2800) in ART and spontaneous pregnancies in infertile couples was significantly higher when compared to the EUROCAT 2.0 versus 3.75 % (p = 0.0002)., Discussion: Babies born after ART treatments and from spontaneous conception in infertile couples had rates of congenital anomalies higher than those recorded by the EUROCAT. However, the rates of anomalies were not different within the infertile population whether conceived by ART or spontaneously. These data suggest that the diagnosis of infertility in itself is the common denominator for the increase in the rates of anomalies seen in both ART and spontaneous conceptions.

Published
2016
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17. Artificial shrinkage of blastocysts prior to vitrification improves pregnancy outcome: analysis of 1028 consecutive warming cycles.

Author

Levi-Setti PE, Menduni F, Smeraldi A, Patrizio P, Morenghi E, and Albani E

Subjects
Adult, Cryopreservation, Embryo Implantation physiology, Embryo Transfer, Female, Humans, Pregnancy, Pregnancy Outcome, Pregnancy Rate, Blastocyst physiology, Embryo Culture Techniques methods, Reproductive Techniques, Assisted, Vitrification
Abstract

Purpose: This study aims to compare implantation, pregnancy, and delivery rates in frozen transfer cycles with blastocysts that were vitrified either with artificial shrinking (AS group) or without (NAS group)., Methods: Retrospective comparative study of artificial shrinking of blastocysts prior to vitrification and frozen embryo transfer cycles in infertile patients undergoing frozen embryo transfer (FET) was done at the Humanitas Fertility Center between October 2009 and December 2013. Main outcome measure(s) were implantation (IR), pregnancy (PR), and delivery rates (DR) between the two groups., Results: A total of 1028 consecutive warming blastocyst transfer cycles were considered. In 580 cycles (total of 822 blastocysts), artificial shrinking was performed prior to vitrification (AS group), while in the remaining 448 cycles (total of 625 blastocysts), the artificial shrinking was not performed (NAS group). There were no differences in patient age (36.4 ± 3.7 vs. 36.3 ± 3.9) and number of embryos transferred (1.41 ± 0.49 vs. 1.38 ± 0.50) between groups. The IR, PR, and DR in the AS group were significantly higher (p < 0.05) than in the NAS group (29.9 vs. 23.0 %, 36.3 vs. 27.9 %, and 26.5 vs. 18.1 %, respectively)., Conclusions: Performing AS of blastocysts prior to vitrification appears to improve implantation, pregnancy, and delivery rates probably related to a decreased risk of ultrastructural cryodamages, plausible when cryopreserving expanded blastocysts.

Published
2016
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18. Ejaculate oxidative stress is related with sperm DNA fragmentation and round cells.

Author

Iommiello VM, Albani E, Di Rosa A, Marras A, Menduni F, Morreale G, Levi SL, Pisano B, and Levi-Setti PE

Abstract

Oxidative stress (OS) plays an essential role in male infertility aetiology by affecting sperm quality, function, and also the integrity of sperm DNA. The assessment of oxidative stress in semen may be an important tool to improve the evaluation of sperm reproductive capacity. The purpose of this study was the evaluation of any possible relation between the unbalance of oxidative stress caused by superoxide anion in the ejaculate with the presence of sperm DNA fragmentation and high concentration of round cells. 56 semen samples from males from couples suffering from infertility were evaluated according to World Health Organisation (WHO) 2010 guidelines. Oxidative stress levels from N1 (low) to N4 (high) were assessed in ejaculates using oxiSperm; DFI (sperm DNA fragmentation index) as assessed by the SCSA (Sperm Chromatin Structure Assay) was used for evaluation of sperm chromatin integrity. Our data show that high oxidative stress (N3-N4 levels) correlated positively with a DFI ≥ 30% (P = 0.0379) and round cells ≥1.500.000/mL (P = 0.0084). In conclusion, OS increases sperm DNA damage. Thus evaluation of semen OS extent of sperm DNA damage in infertile man could be useful to develop new therapeutic strategies and improve success of assisted reproduction techniques (ART).

Published
2015
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19. Experimental contamination assessment of a novel closed ultravitrification device.

Author

Criado E, Moalli F, Polentarutti N, Albani E, Morreale G, Menduni F, and Levi-Setti PE

Subjects
Colony Count, Microbial, Cryopreservation standards, Equipment Design, Equipment Safety, Escherichia coli isolation & purification, Escherichia coli physiology, Humans, Nitrogen, Pseudomonas aeruginosa isolation & purification, Pseudomonas aeruginosa physiology, Reproductive Techniques, Assisted adverse effects, Cryopreservation instrumentation, Equipment Contamination prevention & control, Models, Theoretical, Reproductive Techniques, Assisted instrumentation
Abstract

Objective: To evaluate the safety of a new ultravitrification closed device., Design: Ultravitrification research., Setting: Private assisted reproduction center., Animal(s): Microorganisms (bacteria)., Intervention(s): A styrofoam container holding 1,000 mL of liquid nitrogen (LN2) was contaminated with Pseudomonas aeruginosa and Escherichia coli. Forty closed devices (Ultravit) and 20 open devices (Cryotop) loading approximately 0.5 μL of antibiotic-free medium were plunged into this contaminated LN2 for 5-10 seconds and then inoculated into selective culture dishes. Colony-forming units were analyzed and counted after an overnight incubation at 37°C., Main Outcome Measure(s): Detection of micro-organisms in different devices after incubation., Result(s): There was no contamination in any of the closed devices, whereas in 45% of open devices these bacteria were present., Conclusion(s): With this study we demonstrated, in an experimental model using contaminated LN2, that this new closed device is a safe system that does not allow cell contact with LN2, avoiding cell contamination., (Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Published
2011
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