Clinical performance of an innovative back surface multifocal contact lens in correcting presbyopia

Purpose: This prospective study was designed to subjectively and objectively evaluate the performance of an aspheric multifocal back surface rigid gas permeable (RGP) contact lens. The multifocal element of this lens design consisted of an aspheric optical zone that varied according to the patient's ametropia, corneal topography, and required reading addition.

Methods: We fit 28 presbyopic subjects with an aspheric multifocal back surface RGP contact lens (age range: 45 to 68 years). Reading additions ranged from +0.75 D to +2.50 D. Subjects were assessed initially and at 2, 6, and 12 weeks for ocular changes, visual performance, and subjective responses.

Results: We required 116 RGP lenses to achieve an acceptable fit and visual acuity in 28 subjects (55 eyes). At the final visit, the distance logMAR acuity with the multifocal contact lens (+0.12 +/-0.10) was not statistically different (t=-0.623, P= 0.5388) from spectacle acuity at the initial visit (+0.10 +/-0.12). The near logMAR acuity with the multifocal contact lens at the final visit (0.36 +/- 0.12) was not statistically different from that for near acuity with spectacles at the initial visit (0.33 +/- 0.13). No slit lamp signs worsened during the study. A reduction in myopia of 0.67 D was noted by the final visit. Spectacle blur was noted if the acuity at the initial refraction was compared to the acuity with the same refraction at the final visit (t= -3.287, P= 0.0028) but not when the refractive changes were incorporated (t= 1.058, P= 0.3127). All subjects rated the performance of the lenses very highly: comfort, 86%; distance acuity, 83%; near acuity, 73%; and stability of vision, 74%. Twenty-four subjects (86%) chose the multifocal contact lens as their preference.

Conclusion: We demonstrated that a multifocal design is able to provide acceptable distance and near correction for presbyopic patients. The aspheric geometry required can be optimized for a given patient by considering his/her degree of ametropia, as well as the corneal topography.

An international survey of contact lens prescribing for presbyopia

Purpose:  The aim was to determine world-wide patterns of fitting contact lenses for the correction of presbyopia.

Methods:  Up to 1,000 survey forms were sent to contact lens fitters in each of 38 countries between January and March every year over five consecutive years (2005 to 2009). Practitioners were asked to record data relating to the first 10 contact lens fittings or refittings performed after receiving the survey form.

Results:  Data were received relating to 16,680 presbyopic (age 45 years or older) and 84,202 pre-presbyopic (15 to 44 years) contact lens wearers. Females are over-represented in presbyopic versus pre-presbyopic groups, possibly reflecting a stronger desire for the cosmetic benefits of contact lenses among older women. The extent to which multifocal and monovision lenses are prescribed for presbyopes varies considerably among nations, ranging from 79 per cent of all soft lenses in Portugal to zero in Singapore. There appears to be significant under-prescribing of contact lenses for the correction of presbyopia, although for those who do receive such corrections, three times more multifocal lenses are fitted compared with monovision fittings. Presbyopic corrections are most frequently prescribed for full-time wear and monthly replacement.

Conclusions:  Despite apparent improvements in multifocal design and an increase in available multifocal options in recent years, practitioners are still under-prescribing with respect to the provision of appropriate contact lenses for the correction of presbyopia. Training of contact lens practitioners in presbyopic contact lens fitting should be accelerated and clinical and laboratory research in this field should be intensified to enhance the prospects of meeting the needs of presbyopic contact lens wearers more fully.

Trends in Australian contact lens prescribing during the first decade of the 21st century (2000–2009)

Purpose:  The aim was to document contact lens prescribing trends in Australia between 2000 and 2009.

Methods:  A survey of contact lens prescribing trends was conducted each year between 2000 and 2009. Australian optometrists were asked to provide information relating to 10 consecutive contact lens fittings between January and March each year.

Results:  Over the 10-year survey period, 1,462 practitioners returned survey forms representing a total of 13,721 contact lens fittings. The mean age (± SD) of lens wearers was 33.2 ± 13.6 years and 65 per cent were female. Between 2006 and 2009, rigid lens new fittings decreased from 18 to one per cent. Low water content lenses reduced from 11.5 to 3.2 per cent of soft lens fittings between 2000 and 2008. Between 2005 and 2009, toric lenses and multifocal lenses represented 26 and eight per cent, respectively, of all soft lenses fitted. Daily disposable, one- to two-week replacement and monthly replacement lenses accounted for 11.6, 30.0 and 46.5 per cent of all soft lens fittings over the survey period, respectively. The proportion of new soft fittings and refittings prescribed as extended wear has generally declined throughout the past decade. Multi-purpose lens care solutions dominate the market. Rigid lenses and monthly replacement soft lenses are predominantly worn on a full-time basis, whereas daily disposable soft lenses are mainly worn part-time.

Conclusions:  This survey indicates that technological advances, such as the development of new lens materials, manufacturing methods and lens designs, and the availability of various lens replacement options, have had a significant impact on the contact lens market during the first decade of the 21st Century.

Contact lens prescribing in the Australian states and territories 2001

Background: This study was conducted to ascertain current preferences for contact lens prescribing in the Australian states and territories.

Methods: One thousand questionnaires were randomly distributed to proportionate samples of optometrists in each state of Australia. We requested details of the first 10 patients fitted with contact lenses after receipt of the questionnaire.

Results: One hundred and seventy-eight completed questionnaires were returned, detailing contact lens fits to 1,611 patients. The mean age of the patient group was 32.1 $pL 13.0 yrs (65 per cent female). For Australia as a whole: 53 per cent of patients were existing wearers, the remainder were new fits; 93 per cent of new fits were with soft lenses, of which seven per cent were for extended wear. Of the refits, 89 per cent were soft lenses and 18 per cent for extended wear. The lens material of first choice was mid-water-content (62 per cent of all soft lens fits). Only eight per cent of all soft fits were for lenses that were not replaced on a planned basis, with two weeks being the replacement interval of choice in all states and territories. The majority of rigid lenses were prescribed using mid-Dk materials (50 per cent). Analysis of solution prescribing indicates that multi-purpose products were the most common regimens for planned replacement soft lenses. The percentage of hydrogen peroxide prescribed increased as lens replacement became less frequent. By state or territory: practitioners in Tasmania prescribed more extended wear than those in any other state (p = 0.007) and practitioners in Queensland prescribed more daily disposable contact lenses than those in any other state (p = 0.009).

Conclusions: Non-planned replacement lenses are now rarely prescribed to patients. Extended-wear lenses and rigid lenses continue to be prescribed more to existing contact lens wearers than to new patients. The impact of soft multifocal lens designs on contact lens prescribing is very small, ranging from 2.6 per cent in Queensland to 4.7 per cent in Victoria, despite 20 per cent of patients being more than 45 years of age.

Corneal staining as a response to contact lens wear

Objective: To review the effects of contact lenses on the corneal surface.

Methods: A review of the literature and in-house research of corneal staining and its various forms of presentation.

Results: Corneal staining manifests in many different forms. The severity of staining or insult of the cornea is usually determined by the extent (area of coverage), density, and depth. The cause of staining is multifactorial, and its location is often linked to the type of lens that is being worn, the solution used to clean/disinfect the lens, the state of hydration of the soft lens, and the state of the cornea that has been affected by the lens.

Conclusions: Sodium fluorescein dye effectively highlights corneal integrity changes referred to as corneal staining. This review describes the manifestations, the cause, the mechanisms, and the methods of remediation of corneal staining.

Influence of the blink interval on tear meniscus height in soft contact lens and nonlens wearers

Purpose: Tear meniscus height (TMH) is an indirect measurement of tear film volume. This study investigated the temporal changes in the TMH during the blink interval in the morning (8–9 am) and at the end of the day (5–6 pm) in both soft contact lens (CL) and nonlens wearers (NLW).

Methods: Fifty participants (25 CL; 25 NLW) were evaluated for their subjective symptoms, TMH, noninvasive break up time, and bulbar hyperemia at the am and pm visits on the same day. The TMH was measured at set intervals between 2 and 15 sec during the blink interval, using an optical coherence tomographer.

Results: The NLW group revealed no changes in a variety of symptoms during the day, whereas the CL group reported an increase in dryness (P=0.03) and grittiness (P=0.02) over the day. For both groups, the TMH and calculated tear meniscus volume revealed lower values immediately after the blink and increased progressively afterwards, mainly due to reflex tearing. The am tear meniscus volume values tended to be higher than the pm values for both groups, but this was not significant (NLW P=0.13; CL P=0.82). Noninvasive break up time deteriorated during the day for both groups but was only significant for the CL group (P=0.002), whereas bulbar hyperemia revealed no statistically significant change for either group.

Conclusions: Reflex tearing may play a substantial role in the TMH differences observed over the blink interval. Standardization of the time when a TMH measurement is performed will be valuable in comparing tear film clinical studies.

Utility of short-term evaluation of presbyopic contact lens performance

Objectives: To establish if evaluations of multifocal contact lens performance conducted at dispensing are representative of behavior after a moderate adaptation period.

Methods: Eighty-eight presbyopic subjects, across four clinical sites, wore each of four multifocal soft contact lenses (ACUVUE BIFOCAL, Focus Progressives, Proclear Multifocal, and SofLens Multifocal) for 4 days of daily wear. Comprehensive performance assessments were conducted at dispensing and after 4 days wear and included the following objective metrics: LogMAR acuity (contrast, 90% and 10%; illumination, 250 and 10 cd/m2; distance, 6 m, 100 cm, and 40 cm), stereopsis (RANDOT), reading critical print size and maximum speed and range of clear vision at near. Subjective assessments were made, with 100-point numerical rating scales, of comfort, ghosting (distance, near), visual quality (distance, intermediate, and near), and the appearance of haloes. At two sites, subjects (n = 39) also rated visual fluctuation (distance, intermediate, and near), facial recognition, and overall satisfaction.

Results: Among the objective variables, significant differences (paired t test, P<0.05) between dispensing and 4 days were found only for range of clear vision at near (2.9 ± 2.0 cm; mean difference ± standard deviation) and high contrast near acuity in low illumination (-0.013 ± 0.011 LogMAR). With the exception of insertion comfort, all subjective variables showed significant decrements over the same period. Overall satisfaction declined by an average of 10.9 ± 5.1 points.

Conclusions: Early assessment is relatively unrepresentative of performance later on during multifocal contact lens wear. Acuity based measures of vision remain substantially unchanged over the medium term, apparently because these metrics are insensitive indicators of performance compared with subjective alternatives.

Clinical evaluation of long-term users of two contact lens care preservative systems

Purpose: To clinically evaluate long-term users of two different contact lens care preservative systems and to investigate whether prolonged use is associated with an increase in the prevalence of dry eye.

Methods: Eighty-nine wearers of group IV hydrogel or silicone hydrogel lenses participated in this one-visit, investigator-masked study. Subjects were required to have consistently used a polyhexamethylene biguanide (PHMB) or polyquaternium-1 (PQT) based solution for 2 years. Consistent use was defined as 80% for the past 2 years and 100% for the past year. Clinical assessments included: average and comfortable wear time; overall and end-of-day comfort; signs of dryness, discomfort, burning or stinging, grittiness or scratchiness and visual changes; non-invasive and fluorescein break-up-time; pre-ocular tear film lipids, tear meniscus height, Schirmer and fluorescein clearance tests; limbal and bulbar hyperemia; palpebral roughness; corneal and conjunctival staining; lens front surface wetting; and lens film deposits.

Results: Significantly more grittiness or scratchiness was reported by subjects using a PHMB-containing system (67% vs. 44%; P = 0.02). Palpebral roughness and hyperemia were significantly greater in the PHMB group wearing group IV lenses (P = 0.01 and P = 0.05, respectively). Corneal staining was significantly higher in the PHMB users in all four peripheral sectors (P < 0.01). Nasal and temporal conjunctival staining was also significantly higher for users of PHMB-containing systems (P < 0.05). Front surface lens wettability was significantly better for group IV PQT users compared to PHMB users (P = 0.008), with 84% vs. 72%, respectively, with lenses graded by the investigator as having good or excellent wettability. Significantly higher levels of lens front surface film deposits were noted with PHMB users (P = 0.007), with 58% of group IV lenses treated with PHMB compared with 38% of group IV lenses treated with PQT showing some lens front surface film deposition. No significant differences between the two preservative system groups were noted for the range of dry eye evaluations nor the remaining clinical assessments.

Conclusions: Differences in both ocular and lens characteristic were observed between long-term users of two preservative systems used in many contact lens multi-purpose solutions. The findings from this study did not support the hypothesis that prolonged use of PHMB-containing solutions leads to dry eye. Additional studies including a larger sample size and perhaps longer use of the systems could help to further elucidate differences in clinical performance between systems.