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Pediatrics Landmark Studies

  • Cryotherapy for ROP (CRYO-ROP)
  • Supplemental Therapeutic Oxygen for Prethreshold ROP (STOP-ROP)
  • Early Treatment for ROP (ET-ROP)
  • Bevacizumab for ROP (BEAT-ROP)
  • ATS - Atropine vs. Patch
  • ATS - Patching vs. Correction
  • Atropine in the Treatment of Myopia I (ATOM I)
  • Atropine in the Treatment of Myopia II (ATOM II)
  • Low-Concentration Atropine for Myopia Progression (LAMP)
  • Infant Aphakia Treatment Study (IATS)

Cryotherapy for ROP (CRYO-ROP)

  Colder than the tip of the eyesburg. The multicenter Trial of Cryotherapy for Retinopathy of Prematurity was developed in the 1980s to provide a more evidence-based approach to the treatment of retinopathy of prematurity. More specifically, the study sought to determine the value and outcomes of peripheral ablative treatment (specifically cryotherapy) for the treatment of ROP.


Key Points

  • Treated eyes had a 49.3% reduction in “unfavorable” outcomes based on masked grading of fundus photographs at 3 and 12 months (21.8% in treated, 43.0% in untreated)
  • In the 10 year follow-up, it was noted that anatomic outcomes were better than functional outcomes, meaning outcomes based on imaging may overestimate the impact of treatment


Overall, the CRYO-ROP was a landmark study for both the screening and treatment of ROP, even if the specific treatment has become a secondary one in the time since. The main findings of this study showcase a decreased incidence of blindness and retinal detachment, improved visual acuity outcomes, and improved structural outcomes in eyes treated with cryotherapy. A second-generation study, the ET-ROP, studied laser photocoagulation as ablative treatment, which has now become the paradigm for ROP management.

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Early Treatment for ROP (ET-ROP)

 Is patience still a virtue when managing ROP? The most common cause of pediatric blindness in the United States is retinopathy of prematurity (ROP), a condition characterized by abnormal angiogenesis following incomplete retinal vascularization in premature infants. Surgical management of ROP involves cryotherapy or laser therapy to avascular retina – however prior to the ETROP study, standard of care involved waiting to intervene until risk of retinal detachment or macular folds reached ≥ 50% (“threshold” ROP). ETROP was a randomized control trial to determine whether early ablation for “prethreshold” ROP (risk ≥ 15%) would improve visual acuity and structural outcomes compared to conventional management.


Key Findings:

  • At 9 months of age, early peripheral retinal ablation significantly reduced unfavorable visual (from 19.5% to 14.5%, p=.01) and structural outcomes (from 15.6% to 9.1%, P < 0.001). 
  • Further analysis revealed a new clinical algorithm for early prethreshold ROP treatment: Type 1 ROP (Zone I, any stage ROP with plus disease; Zone I, stage 3 ROP without plus disease; or Zone II, stage 2 or 3 with plus disease) should be managed with immediate intervention, while Type 2 ROP (zone I, stage I or 2 ROP without plus disease or zone II, stage 3 ROP without plus disease) should be closely monitored. 
  • Patients were followed until 6 years of age and the structural benefits of early treatment persisted for eyes with high-risk prethreshold ROP; however, visual acuity benefits were only present for eyes with type 1 ROP.


ETROP was a landmark study that established the current treatment guidelines for ROP, demonstrating the structural and visual benefits of early intervention for eyes with type 1 ROP. However even with early treatment, 65.4% of eyes still developed visual acuity worse than 20/40, indicating the fundamental limitations in ROP management. 

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Amblyopia Treatment Study (ATS) - Atropine vs. Patching

Kids often dress up as pirates, but do they really want to keep their eye patches on after Halloween? Prior to this landmark study in 2002, the corrective treatment for amblyopia correction was almost exclusively patching. Still, concerns around compliance raised the question of whether medical penalization therapy (atropine) could be similarly effective. In this trial, children aged 3-7 with moderate amblyopia were randomized to be treated with either patching or 1% atropine in their non-amblyopic eye.


Key Points:

  • Both patching and atropine led to significant visual improvement, with similar success rates (amblyopic eye VA 20/30 or better: 79% in atropine, 74% in patching)
  • Patching offered a more rapid recovery of vision at 5 weeks, and slightly greater visual improvement at 6 months (3.16 lines vs. 2.84 lines), but this difference was thought to be clinically insignificant
  • Patching compliance was slightly higher in the atropine group (95% in atropine, 83% in patching) 


The importance of this study was showing that both patching and atropine are effective in treating moderate amblyopia in children ages 3-7, with patching improving VA more rapidly and atropine being easier to administer as well as cheaper.

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Atropine for the Treatment of Childhood Myopia (ATOM1)

A drop a day can keep the… glasses away? Myopia is the most common eye disorder in humans and is associated with multiple irreversible blinding conditions including retinal detachment. Prior to this study, atropine was described as an agent that could slow progression, but there had been no long-term, randomized control trials. ATOM 1 is a randomized control trial in which children aged 6-12 with refractive error between -1.00D and -6.00D were randomized to either 1% atropine sulfate or vehicle eye drops once nightly for two years. 


Key Points:

  • Once-nightly dose of 1% atropine eye drops achieved a 77% reduction in progression of myopia over two years (mean progression: 1.20 +/- 0.69D in placebo vs 0.28+/- 0.92 D in atropine)
  • Atropine administration also significantly slowed axial elongation (placebo: 0.38+/- 0.38 mm; atropine: 0.02+/- 0.35 mm)
  • There were no serious adverse effects related to topical atropine use. Side effects included glare, photophobia due to pupillary dilatation, and blurred near vision due to induced cycloplegia 


This study was the first randomized control study to show slowing of myopia progression in children with atropine use. This study has limited extrapolation due to its limited study population (exclusively Asian children) and time course (two years). Additionally, there have been questions as to whether the effect lasted after stopping atropine, something that was examined in ATOM2 study.

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Low-Concentration Atropine for Myopia Progression (LAMP)

Atropine can make you hot as a hare and red as a beet! But can also reduce myopia progression? High myopia is associated with excessive eyeball growth leading to sight-threatening complications down the road. Although concentration-dependent responses in myopia control were evident with higher-concentration atropine eye drops (ATOM study), the role of low-concentration atropine in myopia control was uncertain. This double-blinded, randomized control trial evaluated the efficacy and safety of atropine eye drops at 0.05%, 0.025%, and 0.01% compared with placebo over a 1-year period. 438 children, ages 4 to 12, with myopia of at least −1.0 diopter (D) and astigmatism of −2.5 D or less were included.


Key Points:

  • A significant concentration-dependent response on myopia control (spherical equivalent and axial length change) was observed in all atropine concentrations at 1 year 
  • Changes in accommodation amplitude and pupil size also followed a concentration-dependent response in all groups
  • Visual acuity and vision-related quality of life were not affected


This landmark study demonstrated that low-concentration atropine eye drops reduced both spherical equivalent progression and axial length elongation along a concentration-dependent response, with 0.05% atropine eye drops being the most effective dose in reducing myopia progression.

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The Infant Aphakic Treatment Study (IATS) - 2014

Peekabo! Eye See You! The Infant Aphakic Treatment Study (IATS) sought to compare visual outcomes in infants (aged 1-6 months) with a unilateral congenital cataract following cataract extraction surgery and either intraocular lens (IOL) implantation or left aphakic with contact lens usage. Patients then received the same patching therapy and were followed up for up to 5 years.


Key Points:

  • The average visual acuity is not different between the 2 treatment groups
  • The proportion of adverse events was higher in the IOL group (81%) than contact lens (56%) group.
  • The proportion of additional intraoperative procedures was higher in the IOL group (72%) than the contact lens (12%) group
  • The percentage of participants included in the adherence analyses did not differ by treatment group


The IATS showed that with regards to neutral visual acuity outcomes and increased postoperative complications and intraoperative additional procedures, it is better to leave babies who are operated on in the first 6 months of life aphakic and use a contact lens, with the plan to implant an IOL a few years later. A variety of reasons may account for these findings, including a less-traumatic surgery with fewer reoperations need­ed later in life and a better fitted IOL. Still, for patients whom placing contact lenses may be unreasonable, it is worthy to consider lOL placement weighed against the potential risks to avoid amblyopia.

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