Maryclare DeLuca

Implantation in Children

With the development of posterior chamber lenses and continuous curvilinear capsulorhexis, and with the availability of viscoelastic agents, the use of intraocular lenses (IOLs) in children is becoming more popular. Since 1982, we have implanted posterior chamber IOLs (PC-IOLs) in the capsular bags of 61 cataractous eyes of 46 children and adolescents. The goal was in-the-bag placement facilitated by the use of a small capsulectomy, and, since 1984, by the use of the continuous curvilinear capsulorhexis. Forty-four cataracts were congenital, 13 were traumatic, and 4 were developmental. Cataract extraction with IOL implantation was performed in 16 (26%) preschool cases (ages 2 through 5), in 31 (51%) child cases (ages 6 through 12), and 14 (23%) adolescent cases (ages 13 through 18). Surgical and postoperative complications were minimal. Visual results were good. Fifty-six percent of preschoolers, 87% of children, and 86% of adolescents achieved 20/40 or better best corrected vision, with 79% of the total cohort achieving 20/40 or better. Overall, 35% achieved an uncorrected visual acuity of 20/40 or better. All but two cases had improvement in best corrected vision; if 20/20 was not attained, the cause was mainly due to deprivation amblyopia. Forty-eight percent of patients were within a diopter of emmetropia.

Implantable contact lens for moderate to high myopia: Phase 1 FDA clinical study with 6 month follow-up

Purpose: To assess the short‐term safety and efficacy of the implantable contact lens (ICL™) to treat, moderate to high myopia, Setting: Phase 1 U.S. Food and Drug Administration clinical study of the ICL conducted at four sites in the United States. Methods: Ten patients with myopia of 7,00 diopters (D) or greater had implantation of a Staar Surgical ICL and were examined preoperatively (baseline) and 1 day, 1 week, and 1, 3, and 6 months postoperatively. Mean preoperative myopia was 7.75 D (range 7.25 to 9.37 D): Results: Six months postoperatively, 5 of 10 eyes (50%) had an uncorrected visual acuity (UCVA) of 20/20 or better, and all eyes had a UCVA of 20/30 or better. All eyes had a best spectacle‐corrected visual acuity (BSCVA), of 20/20 or better and 6 eyes (60%), of 20/15 or better. Six eyes (60%) had an improvement of one or more lines of BSCVA. Mean postoperative spherical equivalent was −0.025 D ± 0.47 (SD). Eight eyes (80%) were within ±0.250 D of emmetropia, and all were within ±1.125 D. No intraoperative or postoperative complications or adverse reactions were observed. Conclusions: The results support the short‐term safety, efficacy; and predictability of ICL implantation to treat moderate to high myopia.

Effect of small incision intraocular lens surgery on postoperative inflammation and astigmatism. A study of the AMO SI-18NB small incision lens.

ABSTRACT A single center, single surgeon, randomized, prospective clinical trial was performed comparing the effectiveness of small (3.5 mm to 4.0 mm) incision intraocular lens surgery and a larger (6.0 mm) incision in improving uncorrected visual acuity and reducing postoperative inflammation and surgically induced astigmatism. One hundred twelve eligible unilateral cases were randomized to receive a 3.5 mm to 4.0 mm incision with implantation of an Allergan Medical Optics three‐piece SI‐18NB silicone lens (56 cases) or a 6.0 mm incision with implantation of a three‐piece biconvex poly(methyl methacrylate) lens (56 cases). At one day after surgery, significantly (P <.01) more patients with 3.5 mm incisions had 20/40 or better uncorrected visual acuity than patients with 6.0 mm incisions (45% vs 20%). Forty percent of patients with 6.0 mm incisions vs 14% of patients with 3.5 mm incisions had visual acuities of 20/100 or worse. At one day after surgery, the larger incision group had significantly higher (P < .01) mean keratometric cylinder (2.28 diopters vs 1.28 diopters in the small incision group). The two groups were comparable by three months. Laser flare/cell meter measurements were taken for each group but showed no significant differences in mean flare or cell measurements between the groups.

Effect of posterior chamber intraocular lens design and surgical placement on postoperative outcome.

ABSTRACT Intraocular lens (IOL) design, optical configuration, and placement have potential effects on postoperative outcome. Laboratory studies have suggested that one‐piece, biconvex designs may reduce or delay posterior capsular opacification and that in‐the‐bag fixation of the posterior chamber IOL may reduce inflammation. To document the clinical significance of IOL design and placement, we conducted a randomized, prospective, clinical trial. Six hundred uncomplicated capsulorhexis and phacocmulsification patients were randomized in a three‐factor design to receive an IOL that was one‐piece or threepiece, had a biconvex, piano‐convex, or laser ridge optic, and was bagor sulcus‐fixated. Treatment differences were related to lens placement. Patients with bag‐fixated IOLs had less posterior capsular opacification, fewer YAG laser capsulotomies, a higher percentage of centered lenses, less inflammation, and fewer late posterior capsular striae than those with sulcus‐fixated IOLs. In the latter group, patients with three‐piece IOLs had fewer posterior capsular striae at three months postoperatively. All six occurrences of haptic loop distortion were in patients with three‐piece IOLs. Patients with the one‐piece design had less late inflammation than those with the three‐piece design. Fewer YAG capsulotomies were necessary at one year in patients with the biconvex design than in those with the piano‐convex or laser ridge configurations. Operative complications, endothelial cell loss, and postoperative complications were not IOL‐related.

Posterior Chamber Phakic Intraocular Lens For Hyperopia

PURPOSE A Phase I U.S. FDA clinical study of a plate haptic posterior chamber phakic intraocular lens (STAAR Surgical Implantable Contact Lens) for treatment of hyperopia was conducted at 4 sites in the United States. The purpose of this report is to assess the short-term safety and efficacy. METHODS Ten patients with hyperopia between +2.50 and +10.875 D were implanted in one eye each with the posterior chamber plate phakic intraocular lens and were examined at baseline and 1 day, 1 week, 1, 3, and 6 months after surgery. Mean baseline hyperopia was +6.63 D. RESULTS At 6 months postoperatively, 7 of 10 eyes (70%) had an uncorrected visual acuity of 20/20 or better and 10 of 10 (100%) had 20/40 or better. Eight of ten eyes (80%) had a spectacle-corrected visual acuity within 1 line of baseline; the other two eyes (20%) had an improvement of 3 lines. Mean 6-month postoperative spherical equivalent refraction was +0.20 +/- 0.61D (range, -0.50 to +1.50 D), a reduction of 6.025 D from baseline. Eight of 10 eyes (80%) were within +/-0.50 D of emmetropia, 9 eyes (90%) were within +/-1.00 D, and all eyes (100%) were within +/-1.50 D. No operative or postoperative complications or adverse reactions were observed. CONCLUSIONS Results support the short-term safety, efficacy, and predictability of the STAAR Surgical Implantable Contact Lens (plate haptic posterior chamber phakic intraocular lens) in the treatment of hyperopia.

Hyperopic thermokeratoplasty: Clinical evaluation

ABSTRACT A new procedure, hyperopic thermokeratoplasty (HTK), developed in the Soviet Union for the correction of hyperopia, uses controlled thermal burns of the corneal stroma with a retractable probe tip preset to penetrate the cornea at 95% depth. The coagulations are applied in a radial pattern for spherical hyperopia. Only the peripheral cornea is treated and the effect is titrated by varying the optical zone and number of rays. The thermal effect flattens the peripheral cornea and steepens the central cornea. In this report, we prospectively evaluated the refractive results of a group of 61 HTK patients. Mean preoperative spherical equivalent was 3.9 diopters (D). Mean follow‐up to date is 5.2 months, with 44% of cases evaluated at six months and 31% at one year. The initial effect of surgery (at one day) was a mean decrease in hyperopia of 6.0 D (standard error of the mean [S.E.] = 0.3 D), resulting in a mean spherical equivalent of −2.1 D (S.E. = 0.2 D). There was a steep regression of effect between one clay and two months at which point average refraction was close to emmetropia. After two months, there was a gradual but continuing regression of effect, leveling off after six months. At five to six months, 63% of cases were undercorrected by at least a diopter; at 9 to 12 months, 83% of cases were undercorrected. The overall change in spherical equivalent at each time increased as optical zone size decreased. Adjustments to the surgical prediction software (developed in the Soviet Union) to render it more suitable for U.S. eyes are underway; smaller optical zones and/or more rays will be used to obtain final stable refractive results closer to emmetropia.

Multifocal versus monofocal intraocular lenses visual and refractive comparisons

ABSTRACT In a unilateral prospective clinical trial, 77 cases were randomized to receive a 3M multifocal IOL or a conventional monofocal implant. Multifocal cases had better uncorrected near vision than monofocal cases at the two to four month visit. Thirty percent of the multifocal cases had near acuity J1, while only 4% of the monofocal cases had that acuity. Eighty‐seven percent of multifocal cases and 71% of monofocal cases had near acuities of J1 to J3. With distance correction in place, 54% of multifocal cases had near acuities of J1 to J2, while only 28% of monofocal cases had comparable acuities (P = .04). There have been no serious postoperative complications in either group.

Effect of suture material on postoperative astigmatism

ABSTRACT Two hundred patients were enrolled in a randomized, prospective clinical trial comparing the use of 10‐0 nylon, 10‐0 polypropylene (Prolene®), 11‐0 polyester (Mersilene®), and 10‐0 polyethylene (Novafil®) suture materials on the amount and decay curves of surgically induced astigmatism following intraocular lens (IOL) surgery. Patients with Mersilene and nylon sutures had the highest amounts of induced with‐the‐rule (WTR) cylinder (significantly more than Prolene) at one day after surgery. However, the WTR cylinder decayed rapidly for nylon during the first three months but more slowly for Mersilene because of its lack of stretchability. The Prolene group had the lowest level of induced WTR cylinder at one day, but against‐the‐rule (ATR) drift occurred, leaving cases with ATR astigmatism by a year. The nylon group had the second highest amount of induced WTR cylinder at one day, which had decayed to ATR cylinder by five months. Between one and two years postoperatively, the nylon group experienced a significant ATR shift. The amount of early induced WTR cylinder seemed to be related to the knot‐tying technique and tissue gripping characteristics, whereas the shape of the decay curve was related to the material characteristics of the suture.

Ablation zone centration after photorefractive keratectomy and its effect on visual outcome

Purpose: To determine the relation between ablation zone decentration, measured by corneal topography, and visual and refractive outcome, contrast sensitivity, glare, and subjective reports of halos after photorefractive keratectomy (PRK). Setting: Eye Foundation, University of Missouri‐Kansas City School of Medicine. Methods: This study comprised 70 eyes of 70 patients enrolled into Phase III of the clinical investigation of the VISX 20/20 excimer laser for the correction by PRK of 1.00 to 6.00 diopters of pre‐existing sphere. All patients were treated with 5.0 mm ablation zones. Preoperative and postoperative corneal topography in 67 eyes was done using the EyeSys system. Ablation zone decentration was measured relative to the pupillary center at all postoperative visits as determined from the difference or change map. Results: Mean distance between the ablation zone center and the pupillary center was 0.62 mm ± 0.34 (SD) (range 0.07 to 1.67 mm). Twenty seven of 66 patients with corneal topography (40.9%) had decentrations less than 0.5 mm; decentrations in 6 eyes (9.1 %) were 1.0 mm or more from the pupillary center. No correlation was observed between the magnitude of decentration and 1 year postoperative best spectacle‐corrected acuity (r = −.04, P = .76), uncorrected acuity (r = −.03, P = .84), or spherical equivalent (r = ‐.07, P = .59); preoperative uncorrected acuity (r = .04, P = .73) or spherical equivalent (r = −.02, P = .90); or reduction in spherical equivalent (r = .02, P = .89). The magnitude of decentration was correlated with preoperative spectacle‐corrected acuity (r = −.37, P = .002). There was no difference in contrast sensitivity, glare, or halos between the cases with less than 0.5 mm of decentration and those with 0.5 mm or more of decentration. Conclusions: The degree of ablation zone decentration did not affect postoperative Snellen visual acuity or contrast sensitivity.

Effect of a superficial and a deep scleral pocket incision on the incidence of hyphema

ABSTRACT Deep tunnel scleral pocket incisions were developed to control surgically induced astigmatism following cataract and intraocular lens implantation surgery. A more superficial, shallow scleral pocket incision was developed to reduce the rate of postoperative hyphema. To test its effectiveness, a randomized prospective clinical study was performed. One hundred twenty‐nine eyes of 129 patients were randomized: 66 to receive a deep tunnel pocket and 63 to receive the superficial pocket. In both groups the incision was made 3 mm posterior to the limbus. For the deep pocket cases, a blade setting of 0.27 mm was used and the wound was dissected forward toward the entry site, creating along, deep, narrow tunnel. For the superficial wound cases, a 0.17 mm blade setting was used and the entire wound was dissected to the edge of the anatomic limbus, creating a thin scleral flap. The left side was then fanned out toward the left with the entry site slightly into clear cornea. At one day after surgery, 22 cases (34%) in the deep pocket group and four cases (6%) in the superficial pocket group had hyphemas. The difference in hyphema rates was statistically significant (P < .001).