Dataset Information

One-year results of the Variation of Orthokeratology Lens Treatment Zone (VOLTZ) Study: a prospective randomised clinical trial.

ABSTRACT:

Purpose

To present the 1-year results of the Variation of Orthokeratology Lens Treatment Zone (VOLTZ) Study, which aims to investigate the myopia control effect of orthokeratology (ortho-k) lenses with different back optic zone diameters (BOZD).

Method

Children, aged 6 to <11 years, having myopia -4.00 D to -0.75 D, were randomly assigned to wear ortho-k lenses with 6 mm (6-MM group) or 5 mm (5-MM group) BOZD. Data collection included changes in refraction, vision, lens performance and binding, ocular health conditions, axial length and characteristics of the treatment zone (TZ) area.

Results

The 1-year results of 34 and 36 subjects (right eye only) in the 6-MM and 5-MM groups, respectively, are presented. No significant differences in baseline demographics were found between the groups (p > 0.05). The first-fit success rates, based on satisfactory centration at the 1-month visit, were 100% and 94% respectively. Horizontal TZ size was 0.92 mm and 0.72 mm smaller in the 5-MM group at the 6-month and 12-month visits, respectively (p < 0.05). At the 12-month visit, no significant between-group differences were found in the incidence of corneal staining (low grade only), lens binding and visual performance (all p > 0.05). Axial elongation was slower in the 5-MM group (0.04 ± 0.15 mm) than the 6-MM group (0.17 ± 0.13 mm) (p = 0.001). A significant positive correlation was observed between the horizontal TZ size and axial elongation (r = 0.36, p = 0.006).

Conclusion

Clinical performance of the two ortho-k lenses was similar, indicating that a smaller BOZD (5 mm) did not affect lens performance or ocular integrity. However, a smaller BOZD led to a reduced TZ, with retardation of axial elongation by 0.13 mm compared to conventional 6 mm BOZD ortho-k lenses after one year of lens wear.

SUBMITTER: Guo B

PROVIDER: S-EPMC8251614 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundTo evaluate the long-term effectiveness of orthokeratology (ortho-K) lenses with small treatment zone (STZ) or conventional treatment zone (CTZ) in controlling axial elongation in children with myopia as well as the impact on visual quality. We also sought to determine the effect of retinal visual signal quality on axial elongation.MethodsThis is a prospective randomized controlled study. A total of 140 participants (age ranging from 8 to 12 years) were randomly assigned to wear either STZ or CTZ ortho-K lenses. STZ ortho-K lenses design was achieved by changing the depth of reverse zone and the sagitta height of the optical zone. Using the IOL-Master 500, axial length (AL) was measured at baseline and after 6, 12 and 18 months of ortho-K treatment. Spherical aberration (SA) and corneal topographic parameters were obtained by the Pentacam anterior segment analyzer at baseline and the 1-month follow-up visit, and optical qualities were assessed by optical quality analysis system-II (OQAS-II) at baseline and after 1 month of lens wearing. Optical quality parameters mainly included the modulation transfer function (MTF) cutoff, Strehl ratio (SR), objective scattering index (OSI), and predicted visual acuity (PVA).ResultsA total of 131 participants completed the study, including 68 in the STZ group and 63 in the CTZ group. The STZ group had significantly reduced AL elongation compared to the CTZ group after treatment (12 months: 0.07 ± 0.11 mm vs. 0.14 ± 0.12 mm, P = 0.002; 18 months: 0.17 ± 0.15 mm vs. 0.26 ± 0.16 mm, P = 0.002). The topography in the STZ group showed a smaller treatment zone (TZ) diameter (2.50 ± 0.23 mm vs. 2.77 ± 0.18 mm, P < 0.001), a wider defocus ring width (2.45 ± 0.28 mm vs. 2.30 ± 0.30 mm, P = 0.006), and larger values of total amount of defocus (119.38 ± 63.71 D·mm2 vs. 91.40 ± 40.83 D·mm2, P = 0.003) and total SA (0.37 ± 0.25 μm vs. 0.25 ± 0.29 μm, P = 0.015), compared with the CTZ group. Objective visual quality decreased in both groups (P < 0.001). This was evidenced by a greater decrease in MTF cutoff (- 14.24 ± 10.48 vs. - 10.74 ± 9.46, P = 0.047) and SR values (- 0.09 ± 0.07 vs. - 0.06 ± 0.07, P = 0.026), and an increase in OSI value (0.84 ± 0.72 vs. 0.58 ± 0.53, P = 0.019). PVA9% decreased significantly in the STZ group but not the CTZ group. A statistically significant negative correlation was found between the changes in total SA and MTF cutoff values (r = - 0.202, P = 0.025). AL changes were associated with sex, change of MTF cutoff value, increment of total SA and TZ area.ConclusionsCompared with CTZ ortho-K lenses, STZ ortho-K lenses significantly inhibited axial elongation in children with myopia while moderately reducing their objective visual quality. Axial elongation was affected by retinal visual quality, and it may be a possible mechanism for ortho-K slowing myopia progression. Trial registration This trial is registered at Chinese Clinical Trial Registry on November 5, 2019 with trial registration number: ChiCTR1900027218. https://www.chictr.org.cn/showproj.html?proj=45380.

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