A randomized trial of adding a plano lens to atropine for amblyopia

Pediatric Eye Disease Investigator Group, David K Wallace, Elizabeth L Lazar, Michael X Repka, Jonathan M Holmes, Raymond T Kraker, Darren L Hoover, Katherine K Weise, Amy L Waters, Melissa L Rice, Robert J Peters, Darren L Hoover, Pamela A Huston, Christine J Deifel, Pamela M Racan, Jasbir K Sayal, Kari E Soros, Susanna M Tamkins, Courtney E Ewert, Mariana Nunez, Raynold Crespo, Isaura Gomez, Priya Joshi, Lernik Mesropian, Eva M Olivares, Marlon Parra, Lidia E Salinas, Nicholas A Sala, Jeanine M Romeo, Rhonda M Hodde, Cindy E Tanner, Veda L Zeto, Earl R Crouch Jr, Earl R Crouch 3rd, Gaylord G Ventura, Cynthea M Carlton, Katherine A Lee, Bonita R Schweinler, Derek Beck, Larry W Plum, Benjamin H Ticho, Deborah A Clausius, Megan Allen, Sharon L Giers, Lindsay A Horan, Stephen R Glaser, Stephen R Glaser, Monica M Pacheco, Laura L Graham, Markita G Miller, Noga Senderowitsch, Aliza C Shabanowitz, Wendy L Marsh-Tootle, Sarah D Lee, Robert P Rutstein, Katherine K Weise, Michael P Hill, Calah O Ray, David B Petersen, J Ryan McMurtrey, Patrick J Droste, Robert J Peters, Jan Hilbrands, Misha K Mennega, Jennifer L Mooney, Aaron M Miller, Jorie L Jackson, Michael X Repka, Alex Christoff, Xiaonong Liu, Carole R Goodman, Don L Bremer, David L Rogers, Rae R Fellows, Meghan C McMillin, Amy J Wagner, Lisa J Vanover, Laura B Enyedi, David K Wallace, Terri L Young, Sarah K Jones, Susan A Cotter, Carmen N Barnhardt, Angela M Chen, Catherine L Heyman, Reena A Patel, Sue M Parker, Amy L Waters, Rebecca J Dent, Jason C Cheung, Jason C Cheung, Melissa L Rice, Tiffany M Parypa, Andria E Goddard, Jacque J Ferro, Justin B Smith, Mei L Mellott, Troy L Kieser, Kate A Palitsch, Cynthia L Beauchamp, David R Stager, Angela Goodloe, Daniel J Karr, Allison I Summers, Paula K Rauch, Yelena M Bubnoz, Albert Romo, Jonathan M Holmes, Rebecca A Nielsen, Sarah R Hatt, Todd A Goldblum, Angela Alfaro, Chastity R Escobedo, Christie L Morse, Caroline C Fang, Melanie L Christian, David A Johnson, Kelly L Moulton, Kellie Drake, Raymond T Kraker, Roy W Beck, Nicole M Boyle, Christina M Cagnina-Morales, Courtney L Conner, Danielle L Chandler, Trevano W Dean, Quayleen Donahue, Brooke P Fimbel, James E Hoepner, Joseph D Kaplon, Elizabeth L Lazar, B Michele Melia, Rachel V Orlowski, Diana E Rojas, Jennifer A Shah, Donald F Everett, Eileen E Birch, Susan A Cotter, Donald F Everett, Nicole C Foster, Richard P Golden, Jonathan M Holmes, Sarah K Jones, Raymond T Kraker, Marjean T Kulp, Elizabeth L Lazar, B Michele Melia, David B Petersen, Stacy Pineles, Michael X Repka, Donny W Suh, Gaylord G Ventura, Lisa C Verderber, David K Wallace, Jonathan M Holmes, William F Astle, Darron A Bacal, Roy W Beck, Eileen E Birch, Angela M Chen, Melanie L Christian, Stephen P Christiansen, Susan A Cotter, Earl R Crouch Jr, Eric R Crouch 3rd, Sean P Donahue, Laura B Enyedi, Donald F Everett, Darren L Hoover, Pamela A Huston, Jorie L Jackson, Raymond T Kraker, Marjean T Kulp, Scott R Lambert, Ruth E Manny, Aaron M Miller, David G Morrison, David B Petersen, Michael X Repka, David L Rogers, Robert P Rutstein, Nicholas A Sala, Benjamin H Ticho, David K Wallace, Marie Diener-West, John D Baker, Barry Davis, Donald F Everett, Dale L Phelps, Stephen W Poff, Richard A Saunders, Lawrence Tychsen, Pediatric Eye Disease Investigator Group, David K Wallace, Elizabeth L Lazar, Michael X Repka, Jonathan M Holmes, Raymond T Kraker, Darren L Hoover, Katherine K Weise, Amy L Waters, Melissa L Rice, Robert J Peters, Darren L Hoover, Pamela A Huston, Christine J Deifel, Pamela M Racan, Jasbir K Sayal, Kari E Soros, Susanna M Tamkins, Courtney E Ewert, Mariana Nunez, Raynold Crespo, Isaura Gomez, Priya Joshi, Lernik Mesropian, Eva M Olivares, Marlon Parra, Lidia E Salinas, Nicholas A Sala, Jeanine M Romeo, Rhonda M Hodde, Cindy E Tanner, Veda L Zeto, Earl R Crouch Jr, Earl R Crouch 3rd, Gaylord G Ventura, Cynthea M Carlton, Katherine A Lee, Bonita R Schweinler, Derek Beck, Larry W Plum, Benjamin H Ticho, Deborah A Clausius, Megan Allen, Sharon L Giers, Lindsay A Horan, Stephen R Glaser, Stephen R Glaser, Monica M Pacheco, Laura L Graham, Markita G Miller, Noga Senderowitsch, Aliza C Shabanowitz, Wendy L Marsh-Tootle, Sarah D Lee, Robert P Rutstein, Katherine K Weise, Michael P Hill, Calah O Ray, David B Petersen, J Ryan McMurtrey, Patrick J Droste, Robert J Peters, Jan Hilbrands, Misha K Mennega, Jennifer L Mooney, Aaron M Miller, Jorie L Jackson, Michael X Repka, Alex Christoff, Xiaonong Liu, Carole R Goodman, Don L Bremer, David L Rogers, Rae R Fellows, Meghan C McMillin, Amy J Wagner, Lisa J Vanover, Laura B Enyedi, David K Wallace, Terri L Young, Sarah K Jones, Susan A Cotter, Carmen N Barnhardt, Angela M Chen, Catherine L Heyman, Reena A Patel, Sue M Parker, Amy L Waters, Rebecca J Dent, Jason C Cheung, Jason C Cheung, Melissa L Rice, Tiffany M Parypa, Andria E Goddard, Jacque J Ferro, Justin B Smith, Mei L Mellott, Troy L Kieser, Kate A Palitsch, Cynthia L Beauchamp, David R Stager, Angela Goodloe, Daniel J Karr, Allison I Summers, Paula K Rauch, Yelena M Bubnoz, Albert Romo, Jonathan M Holmes, Rebecca A Nielsen, Sarah R Hatt, Todd A Goldblum, Angela Alfaro, Chastity R Escobedo, Christie L Morse, Caroline C Fang, Melanie L Christian, David A Johnson, Kelly L Moulton, Kellie Drake, Raymond T Kraker, Roy W Beck, Nicole M Boyle, Christina M Cagnina-Morales, Courtney L Conner, Danielle L Chandler, Trevano W Dean, Quayleen Donahue, Brooke P Fimbel, James E Hoepner, Joseph D Kaplon, Elizabeth L Lazar, B Michele Melia, Rachel V Orlowski, Diana E Rojas, Jennifer A Shah, Donald F Everett, Eileen E Birch, Susan A Cotter, Donald F Everett, Nicole C Foster, Richard P Golden, Jonathan M Holmes, Sarah K Jones, Raymond T Kraker, Marjean T Kulp, Elizabeth L Lazar, B Michele Melia, David B Petersen, Stacy Pineles, Michael X Repka, Donny W Suh, Gaylord G Ventura, Lisa C Verderber, David K Wallace, Jonathan M Holmes, William F Astle, Darron A Bacal, Roy W Beck, Eileen E Birch, Angela M Chen, Melanie L Christian, Stephen P Christiansen, Susan A Cotter, Earl R Crouch Jr, Eric R Crouch 3rd, Sean P Donahue, Laura B Enyedi, Donald F Everett, Darren L Hoover, Pamela A Huston, Jorie L Jackson, Raymond T Kraker, Marjean T Kulp, Scott R Lambert, Ruth E Manny, Aaron M Miller, David G Morrison, David B Petersen, Michael X Repka, David L Rogers, Robert P Rutstein, Nicholas A Sala, Benjamin H Ticho, David K Wallace, Marie Diener-West, John D Baker, Barry Davis, Donald F Everett, Dale L Phelps, Stephen W Poff, Richard A Saunders, Lawrence Tychsen

Abstract

Background: Some children have residual amblyopia after treatment with atropine eyedrops for amblyopia due to strabismus and/or anisometropia. We conducted a randomized clinical trial to evaluate the effectiveness of augmenting the effect of atropine by changing the lens over the fellow eye to plano in children with residual amblyopia.

Methods: A total of 73 children 3 to <8 years of age (mean, 5.8 years) with stable residual amblyopia (range, 20/32 to 20/160, mean 20/63(+1)) were enrolled after at least 12 weeks of atropine treatment of the fellow eye. Participants were randomly assigned to continuing weekend atropine alone or wearing a plano lens over the fellow eye (while continuing atropine). The primary outcome was assessed at 10 weeks, and participants were followed until improvement ceased.

Results: At the 10-week primary outcome visit, amblyopic-eye visual acuity had improved an average of 1.1 lines with the plano lens and 0.6 lines with atropine only (difference adjusted for baseline visual acuity = + 0.5 line; 95% CI, -0.1 to +1.2). At the primary outcome or later visit when the best-measured visual acuity was observed, the mean amblyopic-eye improvement from baseline was 1.9 lines with the plano lens and 0.8 lines with atropine only.

Conclusions: When amblyopic-eye visual acuity stops improving with atropine treatment, there may be a small benefit to augmenting atropine therapy with a plano lens over the fellow eye. However, the effect was not statistically significant, and the large confidence interval raises the possibility of no benefit or a benefit larger than we observed. A larger study would be necessary to get a more precise estimate of the treatment effect.

Copyright © 2015 American Association for Pediatric Ophthalmology and Strabismus. Published by Elsevier Inc. All rights reserved.

Figures

FIG 1
FIG 1
Flowchart showing study completion within each treatment group. *One participant in the atropine only group did not complete the 10-week primary outcome examination within the analysis window (8–15 weeks after randomization) and therefore, the visual acuity examination was considered missed for the 10-week primary outcome analysis.

Source: PubMed

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