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Three Part Question

Can [ophthalmic lenses with near add (bifocal and progressive lenses)] [control myopia progression] in [children]?

Clinical Scenario

A mother of an 8-year-old child asks if there are glasses can help with her son’s shortsightedness progression.

Search Strategy

MEDLINE (both PubMed website and PubMed PICO interface) were searched for articles using the following keywords: “child”; “add”, “bifocal” or “progressive” combined with “myopia progression”, “myopia control”, “myopia prevention”, “slow myopia” and “retard myopia”. The search was not limited any publication dates but the selection was filtered to only review and clinical trial. The search results were updated as of 10-May-2017.

Search Outcome

After removal of duplicates, 112 papers found of which 92 irrelevant and 0 of insufficient quality for inclusion. 3 systemic reviews and 17 randomised controlled trials (RCTs) were found. Of the 17 RCTs, 13 RCTs were assessed by the 3 systemic reviews, 4 RCTs were not. Final number of articles to review: 3 systemic reviews and 4 RCTs.

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Saw et al. 2002 Singapore	5 RCTs in bifocal lenses; 1 RCT in progressive lenses	Systemic review (Level I)	Myopia progression in refraction (S.E.)	BFs and PALs showed no effect, in terms of diopter of change per year. Treatment effect summarised in change of diopter per year BFs vs SVLs: from -0.07 to +0.18D (-ve: Favours SVLs; +ve: Flavours BFs), by 4 RCTs; Forest plot: RCT with the largest scale favours SVLs: -0.07D; the 3 RCTs with smaller scale favours BFs: +0.09 to +0.18D with moderate overlapping in their CI boundaries in favours BF zone. PALs vs SVLs: 0.14D (no statistically difference), by 1 RCT.	-
Li et al. 2011 China	3 RCT in bifocal lenses; 6 RCTs in progressive lenses (n=1464)	Systemic review with meta-analysis (Level I)	Myopia progression in refraction (S.E.)	(A) BFs or PALS showed treatment effect of 0.15D at 1 year and 0.24D at 2 years.Meta-analysis treatment results at 1 yearBFs or PALs vs SVLs: 0.15D (95%CI: 0.05 to 0.25), by 5 RCTs n=1058Meta-analysis treatment results at 2 yearBFs or PALs vs SVLs: 0.24D (95%CI; 0.08-0.41), by 7 RCTs n=1244B) Meta-analysis results of 0.25D highlighted in the conclusion part of the review could not be used for interpretation. Such result was derived from combining 9 RCTs' results at the end those studies which were of different study lengths ranged from 1.5 to 3 years.	For (A)Forest plots and the 95%CI distribution patterns of studies involved were not available.For (B)1) Inconsistency: Meta-analysis results were pooled from the end results of the 9 RCTs at their study end without considering the differences in their study lengths.2) Imprecision: The mean difference and 95%Cis results were invalid due to data inconsistency.
Walline et al. 2011 USA	4RCTs in bifocals lenses; 3 RCTs in progressive lenses (n=1266)	Systemic review with meta-analysis (Level I)	Myopia progression in refraction (S.E.)	BFs and PALs showed treatment effect of 0.16D and 0.17D respectively at 1 year. Meta-analysis treatment results at 1 year: BFs vs SVLs: 0.16D (95%CI: 0.01 to 0.32), by 4 RCTs n=417 PALs vs SVLs: 0.17D (95%CI: 0.10 to 0.24), by 3 RCTs n=845 BFs or PALs vs SVLs 0.16D (95%CI: 0.07 to 0.24), by 7 RCTs n=1266	-
COMET 2 study 2011 USA	118 myopic children age 8 to 12 with accommodation lag of at least 0.50D and near esophoria of at least 2 pd were randomised to either PALs or SVLs groups.	Prospective RCT (Level II)	Myopia progression in cycloplegic autorefraction (S.E.)	PALs showed statistically significant effect of 0.28D at 3 years. Treatment effect at 3 years: PALs vs SVLs: 0.28D (statistically significant; 95%CI: 0.01 to 0. 55)	-
Berntsen et al. 2012 USA	85 myopic children age 6-11 with accommodation lag of at least 1.30D and near esophoria of at least 2pd were randomised to either PALs or SVLs group.	Prospective RCT (Level II)	Myopia progression in cycloplegic autorefraction (S.E.)	Without adjustment, PALs showed no effect at 1 year. With adjustment, PALs show 0.18D effect at 1 year. Treatment effect at 1 year: Unadjusted - PALs vs SVLs: 0.07D (p=0.34; 95%CI: -0.08 to 0.23) Adjusted - PAL vs SVLs: 0.18D (p=0.01; 95%CI: 0.04 to 0.32)	1) Results were statistically significant only after adjusting for baseline refractive error, age, sex, ethnicity, and the three covariates imbalanced at baseline (axial length, steep keratometry and outdoor activity). No significant difference was shown before adjustment. 2) Short study period.
Cheng et al. 2014 Canada	135 Chinese age 8-13 years were randomised to 3 groups - BFs, Prismatic BF or SVLs groups. Only subjects with myopia progression rate of at least 0.50D in preceding year were involved in the study.	Prospective RCT (Level II)	Myopia progression in cycloplegic autorefraction (S.E.)	BFs and Prismatic BFs showed statistically significant effect of 0.81D and 1.05D respectively at 2 years. Treatment effect at 3 years: BFs vs SVLs: 0.81D (P<0.001) Prismatic BFs vs SVLs: 1.05D (P<0.001)	1) Selection bias: Quasi-randomization 2) Attribution bias: 10% subjects dropped out
Hasebe et al. 2014 Japan	303 myopic Asian children age 6-12 years were randomised to 3 groups - PAL +1.0 Add, PAL +1.5D Add or SVL groups.	Prospective RCT (Level II)	Myopia progression in cycloplegic autorefraction (S.E.)	PALs +1.50D showed statistically significant effect of 0.27D at 2 years. PAL +1.0D showed no effect. Treatment effect at 2 year: PALs +1.5D vs SVLs: 0.27D (p=0.017) PALs +1.0D vs SVLs: 0.19D (p=0.094)	1) Attribution bias: 106 subjects were excluded due to protocol violation in Korea, another 28 subjects dropped out during the study, left with 169 completed the study at 2 years (44% subjects lost in total).

Comment(s)

Most studies showed little or no effect in slowing myopia progression using bifocal or progressive lenses. Meta-analysis shown a treatment effect of 0.15D to 0.16D at 1 year and 0.24D at 2 years for overall myopic children. The clinical trial by Cheng et al. (2014) showed larger treatment effect of 0.81D to 1.05D in 2 years. However, this is the only study used executive BFs and prismatic executive BFs to try to control myopia in children with at least 0.50D progression in preceding year. More studies are required to confirm the treatment effect of those lenses on children with fast myopia growth rate.

Clinical Bottom Line

Ophthalmic lenses with near add (bifocal and progressive lenses) could provide mild but clinical insignificant effect in controlling myopia progression among children.

References

1. Saw SM; Shih-Yen EC; Koh A; Tan D Interventions to retard myopia progression in children: an evidence-based update. Ophthalmology 2002; 109 (3): 415-21.
2. Li SM; Ji YZ; Wu SS; Zhan SY; Wang B; Liu LR; Li SY; Wang NL; Wang JJ Multifocal versus single vision lenses intervention to slow progression of myopia in school age children: a meta-analysis. Surv Ophthalmol 2011; 56(5): 451-60.
3. Walline JJ; Lindsley K; Vedula SS; Cotter SA; Mutti DO; Twelker JD Interventions to slow progression of myopia in children Cochrane Database Syst Rev 2011; (12)
4. Correction of Myopia Evaluation Trial 2 Study Group for the Pediatric Eye Disease Investigator Group [COMET 2] Progressive-addition lenses versus single-vision lenses for slowing progression of myopia in children with high accommodative lag and near esophoria Invest Ophthalmol Vis Sci 2011; 52(5): 2749-57.
5. Berntsen DA; Sinnott LT; Mutti DO; Zadnik K A randomized trial using progressive addition lenses to evaluate theories of myopia progression in children with a high lag of accommodation Invest Ophthalmol Vis Sci 2012; 53(2): 640-9.
6. Cheng D; Woo GC; Drobe B; Schmid KL Effect of bifocal and prismatic bifocal spectacles on myopia progression in children: three year results of a randomized clinical trial JAMA Ophthalmol 2014; 132(3):258-64.
7. Hasebe S; Jun J; Varnas SR Myopia control with positively aspherized progressive addition lenses: a 2-year, multicenter, randomized, controlled trial Invest Ophthalmol Vis Sci 2014; 55(11): 7177-88.