Self-refraction, ready-made glasses and quality of life among rural myopic Chinese children: a non-inferiority randomized trial.
OBJECTIVE
To study, for the first time, the effect of wearing ready-made glasses and glasses with power determined by self-refraction on children's quality of life.


METHODS
This is a randomized, double-masked non-inferiority trial. Children in grades 7 and 8 (age 12-15 years) in nine Chinese secondary schools, with presenting visual acuity (VA) ≤6/12 improved with refraction to ≥6/7.5 bilaterally, refractive error ≤-1.0 D and <2.0 D of anisometropia and astigmatism bilaterally, were randomized to receive ready-made spectacles (RM) or identical-appearing spectacles with power determined by: subjective cycloplegic retinoscopy by a university optometrist (U), a rural refractionist (R) or non-cycloplegic self-refraction (SR). Main study outcome was global score on the National Eye Institute Refractive Error Quality of Life-42 (NEI-RQL-42) after 2 months of wearing study glasses, comparing other groups with the U group, adjusting for baseline score.


RESULTS
Only one child (0.18%) was excluded for anisometropia or astigmatism. A total of 426 eligible subjects (mean age 14.2 years, 84.5% without glasses at baseline) were allocated to U [103 (24.2%)], RM [113 (26.5%)], R [108 (25.4%)] and SR [102 (23.9%)] groups, respectively. Baseline and endline score data were available for 398 (93.4%) of subjects. In multiple regression models adjusting for baseline score, older age (p = 0.003) and baseline spectacle wear (p = 0.016), but not study group assignment, were significantly associated with lower final score.


CONCLUSIONS
Quality of life wearing ready-mades or glasses based on self-refraction did not differ from that with cycloplegic refraction by an experienced optometrist in this non-inferiority trial.
Henan Eye Institute, Henan Eye Hospital, Henan Provincial People's Hospital and People's Hospital of Zhengzhou University, Zhengzhou, China.|State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.
Zhongqiang
Z
Zhou
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.
Tingting
T
Chen
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.
Ling
L
Jin
Department of Ophthalmology, Huidong People's Hospital, Huizhou, China.
Dongxing
D
Zheng
Guangming Eye Hospital, Yangjiang, China.
Shangji
S
Chen
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.|Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.
Mingguang
M
He
Center for Vision in the Developing World, St Catherine's College, Oxford, UK.
Josh
J
Silver
National Eye Institute, Bethesda, Maryland, USA.
Leon
L
Ellwein
New England College of Optometry, Boston, Maryland, USA.
Bruce
B
Moore
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.|ORBIS International, New York, New York, USA.|Centre for Public Health, Royal Victoria Hospital, Queen's University Belfast, Belfast, UK.
Nathan G
NG
Congdon
D000293:Adolescent; D002648:Child; D002681:China; D004311:Double-Blind Method; D004867:Equipment Design; D005139:Eyeglasses; D005260:Female; D006801:Humans; D008297:Male; D009216:Myopia / Q000503:physiopathology / Q000523:psychology* / Q000628:therapy; D011788:Quality of Life; D012029:Refraction, Ocular / Q000502:physiology*; D042262:Retinoscopy; D012424:Rural Population; D016896:Treatment Outcome; D014792:Visual Acuity
China; children; conventional refraction; conventional spectacles; myopia; ready-made spectacles; rural refractionist; self-refraction; visual function