Investigation of the performance of the menifocal Z gas-permeable bifocal contact lens during continuous wear

Purpose. The Menifocal Z is an alternating vision, concentric, bifocal gas-permeable (GP) contact lens; center distance is connected to near periphery by a smooth transition zone. The lens is produced using tisilfocon A (Menicon Z material), which is approved for up to 30 days of continuous wear (CW). The aim of this study was to evaluate the clinical performance of the Menifocal Z when worn for up to 30 days of CW for 6 months.

Methods. Thirty-five existing GP lens wearers were enrolled in the study. Subjects were fitted with Menifocal Z lenses and follow-up visits were conducted after 2 weeks of daily wear and 1 day, 1 week, 6 weeks, 3 and 6 months of CW. A range of objective and subjective clinical performance measures were assessed, including distance and near visual acuity, the physiological response to CW, and subjective evaluation of vision and comfort.

Results. Twenty-seven subjects (77%) completed the study and eight (23%) discontinued: five (14%) as a result of lens-related problems (four vision, one comfort) and three (9%) as a result of non-lens related reasons. Average CW time achieved by the subjects was 22 ± 2 days. Mean binocular logarithm of the minimum angle of resolution (logMAR) acuities at 6 months were: high contrast distance 0.03 (20/20-), low contrast distance 0.63 (20/80-), and high contrast near 0.26 (20/25, N4). Adverse responses and lens binding were minimal, and there were no significant increases in corneal staining, corneal vascularization, or superior palpebral conjunctival papillae over time (p > 0.05). Problems with night vision (distance and near) with the lenses were the most common difficulties reported by the subjects.

Conclusions. The Menifocal Z appears to be a promising option for presbyopic vision correction, providing successful correction of distance and near vision in a group of experienced GP lens wearers. The hyper Dk tisilfocon A (Menicon Z) material allowed for safe wear of the lenses on a CW basis.

The parameter stability of a high dk rigid lens material

The use of rigid materials with high oxygen permeability (Dk) is on the increase, their major benefit being the reduction of hypoxia. However, there is a reluctance to use these materials possibly due to increased surface scratching, reduced wettability, increased deposition, reduced life expectancy and parameter instability. Considering parameter stability, various studies have demonstrated contradictory results or used high Dk materials based on the silicone acrylate polymer. This study was designed to investigate whether the parameters of a high Dk rigid fluorocarbon contact lens material changed during daily wear and extended wear schedules. Thirty five subjects, divided into group groups, Group I wore the lens on a daily wear basis, whereas those in Group II wore the lens on a monthly extended wear basis. The parameters and integrity of the lenses were monitored in both groups every 3 months. For lens integrity a statistically significant increase in surface scratching was demonstrated for the lenses worn by the subjects of both groups over the time of the study (Group I, F=7.990, P <0.0001 [ANCOVA]; Group II, F=6.241, P=0.003 [ANCOVA]). The only parameter to show a statistically significant variation over the study period was that of centre thickness for the lenses worn by the subjects in Group I (F=3.976, P=0.0063 [ANCOVA]), with a mean reduction in centre thickness of 0.022 mm at the 12 month visit.

No change was noted for either group or between groups for the other parameters measured. This study demonstrates that the parameters of rigid contact lenses manufactured from high Dk fluorocarbons are stable with only a non-clinically significant reduction in centre thickness for the contact lenses worn by the subjects in Group I.