Evaluation of visual acuity and color vision in normal human eyes with a sutureless temporary amniotic membrane patch

To evaluate how sutureless amniotic membrane patches may affect visual functions in normal human eyes.

Prospective intervention study.

Ten sets of sutureless amniotic membrane patch manufactured as PROKERA were inserted in one eye of six normal patients. Four sets (one each) were inserted in four patients, while six sets (three each) were inserted in two patients. Uncorrected distant and near visual acuities, color vision, amniotic membrane thickness measured by pachymetry, and total symptom scores were compared before and after insertion.

Within 30 minutes after insertion, mean distant visual acuities decreased from -0.22 +/- 0.06 to 0.92 +/- 0.45 logarithmic minimum angle of resolution (logMAR). Among 10 sets of PROKERA inserted, the largest optotype (1.0 logMAR) of the near vision chart could not be recognized in five, but color vision evaluated by Panel D-15 was still preserved in all. Total symptom scores increased to 47.8 +/- 9.1 points (maximum, 100 points). Among symptoms, total scores for foreign body sensation (17.8 +/- 3.6) and blurred vision (17.8 +/- 4.4) were high. Loss of distant visual acuity and increases of symptom scores were not correlated with amniotic membrane thickness, of which the mean was 67.6 +/- 25.2 mum. However, amniotic membrane that was less opaque tended to provide relatively good visual acuities.

Because of the relative non-transparency of sutureless amniotic membrane patches in PROKERA, distant and near visual acuities decreased in normal human eyes. The foreign body sensation noted after insertion is primarily derived from the rigid supporting skirt.