The VEPRO trial: a cross-over randomised controlled trial comparing 2 progressive lenses for patients with presbyopia.
The aim of this trial was to compare the effectiveness of two generations of progressive lenses for presbyopia.


METHODS
A multicenter cross-over randomized controlled trial performed in a primary care setting (5 optical dispensaries) was planned. Two categories of progressive lenses were compared: 1) a new-generation lens (i.e., VARILUX PANAMIC ORMA CRIZAL), which is expensive but a supposed improvement in comfort, and 2) an older-generation lens (i.e., VARILUX CONFORT ORMA CRIZAL), which is less expensive and is considered the reference lens. Patients were randomized to wear one generation of progressive lens for 4 weeks, then cross over to wear the other lens for 4 weeks, without knowing the sequence of lenses. Inclusion criteria were 1) age 43-60 years; 2) outpatients already wearing progressive lenses and referred to an optician ophthalmologist for optical correction prescription within the last 6 months; 3) receiving a correction of </=3 dioptres in cases of associated myopia, hyperopia or astigmatism; 4) understanding and speaking French and able to answer a questionnaire; and 5) giving written consent to participate in the study.The primary outcome was patient preference for one progressive lens at week 8. Secondary outcomes were subjective measures of bifocal visual performance, including a) near visual acuity, b) visual field, c) kinetic visual skills, d) visual adaptability, e) visual comfort, and f) rapidity of adaptation.


RESULTS
127 patients were randomized to one of the lens groups. Two patients withdrew prematurely; 98.4% and 97.6% patients who wore the new versus older lenses, respectively, wore their progressive lenses every day during the 4-week period 1 and period 2. The number of participants in each of 5 centres varied from 16 (12.6%) to 35 (27.6%).57.9% patients preferred the new-generation lenses, 36.5% the older-generation lenses, and 5.6% had no preference (p = 0.01). The two groups did not differ in any of the measures of bifocal visual performance except near visual acuity.


CONCLUSIONS
Patients with presbyopia had slightly higher preference for the new-generation than older-generation lens, with no difference in lens groups for most of the visual outcomes assessed.


BACKGROUND
ClinicalTrials.gov NCT00635115.
Boutron
Isabelle
I
INSERM, U738, Paris, France, Université Paris, 7 Denis Diderot, UFR de Médecine, Paris, France, AP-HP, Hôpital Bichat, Département d'Epidémiologie, Biostatistique et Recherche Clinique, Paris, France. isabelle.boutron@bch.aphp.fr
Touizer
Caroline
C
Pitrou
Isabelle
I
Roy
Carine
C
Ravaud
Philippe
P