A randomized intraindividual comparison of the accommodative performance of the bag-in-the-lens intraocular lens in presbyopic eyes.

PURPOSE: To compare the accommodative performance of the Morcher BioComFold Type 89A bag-in-the-lens intraocular lens (IOL) with a conventional in-the-bag control IOL in presbyopic eyes.

DESIGN

Prospective, randomized clinical trial with intraindividual comparison.

SETTING

Department of Ophthalmology, St. Thomas' Hospital, London, United Kingdom.

STUDY POPULATION: Fifty-two eyes of 26 patients with bilateral age-related cataracts.

INTERVENTION: Phacoemulsification cataract extraction with implantation of a bag-in-the-Lens and a control IOL, the Alcon AcrySof SA60AT (Alcon Laboratories, Fort Worth, Texas, USA), randomized to either eye.

MAIN OUTCOME MEASURES: Axial IOL shift stimulated by physiologic (near visual effort) and pharmacologic (pilocarpine and cyclopentolate) accommodative stimulation was measured objectively with partial coherence interferometry. Other outcome measures were objective and subjective accommodation, logarithm of the minimal angle of resolution distance-corrected near visual acuity, and defocus curves.

RESULTS

Three months after surgery, axial IOL shift stimulated by near visual effort measured -5.9 ± 10.3 μm in bag-in-the-lens eyes versus -8.4 ± 12.8 μm in control eyes (P = .37), that stimulated by pilocarpine measured 20.2 ± 165.6 μm versus 50.4 ± 164.4 μm (P = .36), and that stimulated by cyclopentolate measured -65.8 ± 64.3 μm versus -54.0 ± 37.5 μm (P = .34), respectively (n = 25). Objective accommodation measured 0.03 ± 0.18 diopters (D) in bag-in-the-lens eyes versus 0.08 ± 0.21 D in control eyes (P = .40), whereas subjective accommodation measured 2.48 ± 0.72 D versus 2.45 ± 0.80 D (P = .75), respectively. Distance-corrected near visual acuity and defocus curves showed no difference between IOLs.

CONCLUSIONS

The bag-in-the-lens IOL demonstrated negligible axial shift and objective accommodation with physiologic near visual stimulation. The IOL shift demonstrated with pilocarpine also was clinically insignificant. The bag-in-the-lens IOL showed no accommodative or near visual advantage over a conventional in-the-bag IOL, despite its unique capsular fixation method. This provides further evidence that the focus-shift principle fails to produce clinically significant IOL movement.