Long-term safety of in-the-bag implantation of a supplementary intraocular pinhole

Abstract

Purpose: To evaluate the long-term effectiveness and safety of the XtraFocus intraocular pinhole (IOPH) when it is implanted inside the capsular bag. Setting: Private practice. Design: Retrospective consecutive case series. Methods: Patients who had an IOPH implanted in the capsular bag together with the primary intraocular lens (IOL) to treat irregular corneal astigmatism secondary to multiple causes were enrolled. The mean follow-up was 16 months (range 7 to 48 months). Patients were assessed in their scheduled follow-up visits. The uncorrected and corrected distance visual acuities were recorded at each visit. An infrared slitlamp photograph was captured and analyzed to verify the presence of interlenticular membrane formation. Results: Sixty eyes of 58 patients were analyzed. The mean uncorrected and corrected distance visual acuities improved from logarithm of the minimum angle of resolution 1.34 ± 0.338 and 0.57 ± 0.145 preoperatively to 0.14 ± 0.012 (P < .001) and 0.12 ± 0.008 (P = .001) at 1 year postoperatively, respectively. A mild pinhole decentration was noted in 5 eyes (8.3%). Interlenticular opacification (ILO) was not noted in any patient. Conclusions: Implantation of the XtraFocus IOPH inside the capsular bag was a safe technique. Improvement observed in both uncorrected and corrected distance visual acuities was significant and sustained over time. ILO did not occur when this implant was positioned in the capsular bag together with a primary IOL.

Review of surgical devices using small aperture optics

“…Rigid contact lenses are the main treatment for irregular corneal astigmatism but some are unable to get an adequate fitting or cannot tolerate them. [ 6 ] There are others who do not qualify for laser refractive surgery or intracorneal ring segments due to inadequate corneal thickness or ocular surface health. [ 32 ] All these patients can benefit from the piggyback XtraFocus device, found to be safe and effective in improving the vision of those with irregular corneal astigmatism or iris defects be it implanted monocularly or binocularly in the ciliary sulcus or capsular bag.…”

“…The statistically significant improvements after XtraFocus device implantation for UDVA and CDVA from baseline values were sustained up to 4 years of follow-up. [ 6 ] In the study by Ho et al ., all their patients had poor vision or glare preoperatively due to a standalone iris defect or coexisting irregular astigmatism and iris defect. [ 32 ] After XtraFocus implantation, 90.9% had better UDVA and 72.7% reported satisfaction with the improved vision or lessened glare.…”

“… a First author and year study was published, b XtraFocus device implanted in the ciliary sulcus of pseudophakic patients with monofocal IOL, c XtraFocus device implanted in the capsular bag at the time of cataract surgery together with a primary IOL, d Bilateral XtraFocus device implanted in the ciliary sulcus of pseudophakic patients or in the ciliary sulcus or capsular bag of phakic patients right after the cataract surgery or refractive lens exchange, e Binocular values, f XtraFocus device implanted in the ciliary sulcus of pseudophakes with standalone iris defect or iris defect with coextisting corneal irregular astigmatism, † All studies include patients with irregular corneal astigmatism, and all values were from the 1 year postoperative follow-up. [ 6 8 32 33 ] CDVA=Corrected distance visual acuity, CNVA=Corrected near visual acuity, F/U=Follow-up, J=Jaeger, n =Number of eyes, NA=Not available, SE=Spherical equivalent, UDVA=Uncorrected distance visual acuity, UNVA=Uncorrected near visual acuity …”

“…[ 32 ] Dilated infrared photography showed no interlenticular opacification for up to 4 years postoperatively. [ 6 ] The authors noted that this was possibly due to the posterior concave shape of the IOL that reduced contact with the other IOL inside the bag while its central hole allowed exit of lens cells through aqueous movement. [ 6 ] Nd:YAG laser posterior capsulotomy was done with no difficulty using a Peyman contact lens to improve focus and if needed, the capsulotomy could be sized larger than the pinhole by modifying the patient gaze.…”

“…[ 6 ] Nd:YAG laser posterior capsulotomy was done with no difficulty using a Peyman contact lens to improve focus and if needed, the capsulotomy could be sized larger than the pinhole by modifying the patient gaze. [ 6 33 ]…”