Study methods and results
Over a three-year period, 104 patients with dislocations of their in-the-bag IOLs were randomized to undergo either scleral suturing of the original IOL (n=54) or to IOL exchange with a new retropupillary fixated iris-claw IOL (n=50) in this prospective, randomized, parallel-group clinical trial.
The same surgeon performed all of the surgeries. The repositioning surgery involved looping of a 10-0 prolene suture around each IOL haptic and fixation to the scleral wall. The exchange procedure involved explantation of the IOL capsule complex through a 5.5-millimeter scleral pocket frown incision.
An aphakic iris-claw IOL (Verisyse, VRSA54, Abbott Laboratories) was then introduced and retropupillary fixated to the iris, according to Dr. Dalby, who is a PhD candidate from the Department of Ophthalmology, Oslo University Hospital, Oslo, Norway.
Eighteen patients could not participate after 2 years because of severe illness, another 18 died, one declined to participate, and one moved out of the country. The average age of the 66 patients who remained in the study was 79.6 years versus 85.2 years for those who left the study.
Examinations were conducted preoperatively and then at six months and one and two years postoperatively. During these examinations, two ophthalmologists and optometrists measured the CDVA and intraocular pressure and conducted slit-lamp examination of the anterior and posterior segments and slit-lamp photography of the anterior segment. The examiners any degree of IOL decentration compared with baseline and graded the IOLs on a scale of one to four, with one indicating a small decentration with a gap between the pupillary edge and the IOL with the optic still covering the visual axis and four indicating complete IOL dislocation.