Table 1.
Summary of clinical trials of antimuscarinic drugs as myopia control treatments.
| Authors (year) |
Age of subjects (years); treatment period |
Initial refractive error (D) |
Key study features |
Treatment q.h.s. unless otherwise specified (subjects; n) |
Control (subjects; n) |
Cycloplegic refractions (Y/N; agent) |
Mean refractive error change in treatment and control groups, respectively, in D/year (SD) |
Mean axial length increase in treatment and control groups, respectively, in mm/year (SD) |
Ref. |
|---|---|---|---|---|---|---|---|---|---|
| Bedrossian et al. (1966) | 7–13; 1 year | −0.5 to −5 | M, NR | 1% Atr or Scop drops (35) | Untreated fellow eye (35) | Y, 1% Tp | +0.18*; −0.91 | NA | [28] |
| Bedrossian (1971) | 7–13; 2 years | 0 to −5 | M, NR | 1% Atr or Scop drops (75) | Untreated fellow eye (75) | Y, 1% Tp | +0.20; −0.85 | NA | [29] |
| Gimbel (1973) | 5–15; 1 year | <0.25 | NM, NR | 1% Atr drops; frequency varied (279) | Untreated myopes (572) | Y, 1% Tp | +0.59; −0.61 | NA | [32] |
| Bedrossian (1979) | 8–13; 2 years | −2.3 (average) | M, R | 1% Atr drops (90) | Untreated fellow eye (90) | Y, Tp | +0.17; −0.99 | NA | [30] |
| Brodstein et al. (1984) | 0–18+; 1–107 months | <−0.5 | NM, NR | 1% Atr drops + BF (222) | Untreated myopes (146) | Inconsistent | −0.01 (0.03); −0.03 (0.02) | NA | [49] |
| Gruber (1985) | 2–21; 1–2 years | ? | NM, NR | 1% Atr drops (100) | Untreated myopes (100) | ? | −0.11; −0.28 | NA | [227] |
| Yen et al. (1989) | 6–14; 1 year | −0.5 to −4.0 | M, R | 1% Atr drops; q.o.d. (32) or 1% Cp drops (32) | Saline drops (32) | Y, 1% Cp + 1% Tp | −0.22 (0.54)*; −0.58 (0.49)*; −0.91 (0.58) | NA | [228] |
| Chou et al. (1997) | 10.6 (average); 26–48 or 28–48 months | −6.25 to −12.0 | M, NR | 0.5% Atr drops + BF (12) or 0.5% Atr drops + BF (8) | Pretreatment Tp (12) or pretreatment untreated (8) | Y, 0.5% Tp | −0.01 (0.04)*; −0.12 (0.09); −0.04 (0.06)*; −0.14 (0.07) (D/month) | NA | [50] |
| Shih et al. (1999) | 6–13; up to 2 years | ? | M?, R | 0.5% Atr, or 0.25% Atr, or 0.1% Atr all drops | Placebo drops | ? | −0.04 (0.63)*; −0.45 (0.55)*; −0.47 (0.91)*; −1.06 (.61) | NA | [46] |
| Romano et al. (2000) | 5–15; 2–24 months | ? | NM, NR | 1% Atr drops + BF always compliant (19) | Partially compliant (12) or never compliant to treatment (4) | Y, 1% Cp | +0.07; −0.18; −0.17 | NA | [40] |
| Chiang et al. (2001) | 6–16; >10 years | <−0.5 | NM, NR | 1% Atr drops + BF (496) | Partially compliant to treatment (210) | ? | 0.08*; 0.23 | NA | [41] |
| Syniuta et al. (2001) | 4–13; 3–96 months | <−6.0 | R, M | 1% Atr (drops?) + BF (15) | Untreated myopes (15) | Y, 1% Cp | 0.05 (0.67); 0.84 (0.26) | NA | [229] |
| Shih et al. (2001) | 6–13; 18+ months | −3.3 (average) | R, NM | 0.5% Atr drops + MF (66) | Placebo drops + MF (61) or + SV (61) | Y, 1% Tp | −0.42 (0.07)**; −1.19 (0.07); −1.40 (0.09) (progression after 18 months) | 0.22 (0.03)**; 0.49 (0.03) | [38] |
| Kennedy et al. (2000) | 6–15; 18 weeks–11.5 years | 0 to −9.2 | R, M | Atr (frequency and dose unknown) (176) | Untreated myopes (retrospective data) | Inconsistent | 0.16*; 0.35 (noncyclopleged) | NA | [230] |
| Siatkowski et al. (2004) | 8–12; 1 year | −0.75 to −4.0 | R, M | 2% Pir gel; b.i.d (174) | Placebo gel (57) | Y, 0.5% Prop + 1% Cp + 1% Tp | −0.26 (0.36)**; −0.53 (0.50) | 0.19 (0.24); 0.23 (0.35) | [53] |
| Tan et al. (2005) | 6–12; 1 year | −0.75 to −4.0 | R, M | 2% Pir gel; b.i.d or q.d | Placebo gel | Y, 0.5% Prop + 1% Cp + 1% Tp | −0.47**; −0.70; −0.84 | 0.33*; 0.30*; 0.20 | [52] |
| Lee et al. (2006) | 6–12; 1 year | −0.5 to −5.5 | NM, NR | 0.05% Atr drops (21) | Untreated myopes (36) | Y, 1% Cp + 1% Tp | −0.28 (0.26)**; −0.75 (0.35) | NA | [47] |
| Chua et al. (2006) | 6–12; 2 years | −1.0 to −6.0 | M, R | 1% Atr drops (166) | Vehicle drops, fellow eye (190) | Y, Prop + 1% Cp | −0.28 (0.92)**; −1.20 (0.69) (progression after 2 years) | 0.02 (0.35); 0.38 (0.38) (>2 years) | [43] |
| Fan et al. (2007) | 5–10; 1 year | <−3.0 | M, NR | 1% Atr ointment (23) | Untreated myopes (23) | Y, 1% Cp | +0.06 (0.79)**; −1.19 (2.48) | 0.09 (0.19)**; 0.70 (0.63) | [22] |
| Liang et al. (2008) | 6–15; ≥6 months | <−0.5 | M, R | 0.5% Atr (23) or 0.25% Atr (26) + AA; all drops | 0.25% Atr drops | Y, 1% Cp | −0.15 (0.15)*; −0.21 (0.23)*; −0.38 (0.32) | 0.12 (0.12); 0.14 (0.11); 0.16 (0.09) | [24] |
| Fang et al. (2010) | 6–12; ≥1 year | (+1 to −1 D) | M, NR | 0.025% Atr (24) | Untreated premyopes (+1 to −1 D) (26) | Y, 1% Cp + 1% Tp | −0.14 (0.24)**; −0.58 (0.34) | NA | [231] |
Frequency of administration is daily unless otherwise noted. Studies are only listed if annual refractive error changes were included in the study.
*
p ≤ 0.05;
**
p ≤ 0.01.
AA: Stimulation with auricular acupoints; Atr: Atropine; BF: Bifocal glasses; b.i.d: Twice daily; Cp: Cyclopentalate; Drops: Eye drops; M: Matched groups; MF: Multifocal glasses; N: No; NA: Not available; NM: Groups not matched; NR: Not randomized; Pir: Pirenzepine; Prop: Proparicaine; q.h.s.: Every night; q.o.d.: Every other day; R: Randomization; Scop: Scopolamine; SD: Standard deviation; SV: Single-vision glasses; Tp: Tropicamide; Y: Yes.