Characterization of the aspheric corneal surface with intrastromal corneal ring segments.

PURPOSE: Anterior corneal surface asphericity was examined in eyes of Phase II clinical trial participants, before and after intrastromal corneal ring segments (ICRS, Intacs) refractive surgery, and surveyed for relationship to clinical visual performance. METHODS: Aspheric test objects with surface asphericity (Q) ranging from -0.01 Q to -1.44 Q and base radius of curvatures ranging from 7.5 mm to 9.0 mm were measured topographically using videokeratography. Radius of curvature asphericity profile plots were produced for test objects and compared to similar plots created for trial participant eyes (n=25) to quantify corneal asphericity. The potential effects of different amounts of corneal asphericity were assessed using measurement of uncorrected and spectacle-corrected visual acuity and photopic contrast sensitivity. RESULTS: Preoperative corneal asphericity ranged from -0.01 Q to -0.81 Q and postoperative from -0.01 Q to -1.44 Q. Preoperative uncorrected visual acuity was significantly related to corneal asphericity; more myopic eyes tended to have more prolate corneal asphericity. Corneal asphericity was not significantly related to spectacle-corrected visual acuity or photopic contrast sensitivity, before or after surgery. CONCLUSION: Postoperative corneal asphericity values demonstrated that intrastromal corneal ring segments (Intacs) produced a prolate aspheric surface for myopic correction from -1.00 D to -6.00 D. This study indicated that the range of corneal asphericity measured in these 25 eyes, before and after surgery, provided good visual acuity and normal contrast sensitivity.     

圆锥角膜基质环植入术的研究进展

角膜基质环植入术(ICRS)是一种用于治疗轻中度圆锥角膜的手术方法。ICRS是通过植入基质环,使中央角膜扁平化,弧长缩短,角膜曲率半径增大,屈光力降低,从而改善角膜前突导致的轴性近视眼与不规则散光。ICRS具有微创性、安全性、有效性、可逆性且并发症少等优点,其中长期疗效较佳。本文中笔者就ICRS的发展史、适应症、手术方法、手术疗效的影响因素、术后处理及疗效的评估等方面进行阐述。     

Ferrara intrastromal corneal ring segments for severe keratoconus

PURPOSE: Intrastromal Ferrara ring segments were inserted in eyes with severe keratoconus to evaluate safety and efficacy of this procedure. METHODS: Intrastromal Ferrara ring segments were placed in 36 eyes of 35 patients with severe keratoconus, who were evaluated after 12 months of follow-up. All patients had highly disabling visual acuity, contact lens intolerance, and a previous indication for penetrating keratoplasty. Statistical analysis included preoperative and postoperative uncorrected visual acuity, best spectacle-corrected visual acuity, manifest refraction, anterior chamber depth, keratometry, and pachymetry. RESULTS: No patient had a loss of visual acuity. Uncorrected visual acuity improved in 28 eyes (77.78%) and best spectacle-corrected visual acuity improved in 29 eyes (80.56%). Spherical equivalent refraction decreased from -7.29 +/- 3.12 D to -4.80 +/- 3.04 D at 12 months after Ferrara intrastromal ring segment implantation. Corneal topography and ultrasound biomicroscopy showed corneal flattening, demonstrated by thinning of the central cornea and a reduction in anterior chamber depth. Segment decentration occurred in one eye (2.7%), asymmetric positioning of the segments in two eyes (5%), inadequate depth in two eyes (5%), migration of the segments in two eyes (5%), segment extrusion in five eyes (13.8%), conjunctivitis in one eye (2.7%), bacterial keratitis in one eye (2.7%), and hydrops in one eye (2.7%). CONCLUSIONS: With these early results, Ferrara intrastromal ring segments appear to be an alternative for the treatment of severe keratoconus.     

Reversibility and exchangeability of intrastromal corneal ring segments

PURPOSE: To evaluate the effect of removal and/or exchange of intrastromal corneal ring segments (ICRS, Intacs); specifically the risk factors, degree of reversibility, and visual outcomes. SETTING: Gimbel Eye Centres, Calgary, Edmonton, and Vancouver, Canada. METHODS: Prospective cohort data were collected on 71 eyes that had ICRS placement by 3 surgeons at the Gimbel Eye Centres between August 1998 and July 1999. Data included patient symptoms, best spectacle-corrected visual acuity, uncorrected visual acuity (UCVA), manifest refraction, reason for removal or replacement, keratometry, corneal topography, and complications. RESULTS: Twenty-four eyes (33.8%) had exchange or removal procedures because of underresponse, 20 eyes; overresponse, 2 eyes; and induced astigmatism and shallow placement, 1 eye each. Secondary procedures were removal and replacement, removal with subsequent laser in situ keratomileusis, and segment repositioning. Two risk factors for secondary surgery were identified: high preoperative refractive astigmatism and postoperative spherical equivalent greater than +/-0.5 diopter (D). The 6 eyes that had ICRS removal stabilized to within +/-0.25 D of the original refractive error with no surgically induced astigmatism within 1 to 7 weeks (mean 4 weeks) and had a final UCVA of 20/20 or better. In the 15 eyes that had ICRS exchange procedures, the UCVA improved by at least 1 line and median UCVA improved from 20/40 to 20/20. CONCLUSION: Preliminary data from this study indicate that removal of segments resulted in reversal of the refractive effect.     

Keratitis after implantation of intrastromal corneal ring segments

A 53-year-old man had implantation of 2 intrastromal corneal ring segments (Intacs, Addition Technology Inc.) in the left eye. Several days after the lower segment was exchanged, an infiltrate was present at the corneal incision site. This progressed to a lower channel infection followed by diffuse keratitis. Culture from the conjunctiva was positive for Staphylococcus epidermidis, but cultures from the cornea were negative for microorganisms. Later, 2 gas bubbles appeared at the interface. The patient was treated with topical and subconjunctival antibiotics and channel irrigation. The keratitis resolved, leaving a neovascularized opacity at the nasal part of the lower channel.     

Confocal microscopy after implantation of intrastromal corneal ring segments

OBJECTIVE: Confocal in vivo real-time microscopy was used to study the corneal morphologic features in eyes after Intrastromal Corneal Ring Segments (ICRS; now called KeraVision INTACS, KeraVision, Inc., Fremont, CA) implantation. DESIGN: Noncomparative, interventional case series. PARTICIPANTS: The authors performed confocal real-time microscopy on a total of 21 eyes from 11 patients. Seventeen eyes from 10 patients (five female, five male; mean age 32.3 years; range 22-42 years) underwent uncomplicated ICRS surgery to correct myopia and were examined after surgery (average 8.6 months; range 2-15 months). Three patients had the ICRS implanted into only one eye, and those eyes were compared with the untreated fellow eyes. One eye of another patient was examined 1 and 6 months after ICRS removal. INTERVENTION: Flying slit-confocal microscopy was performed with water immersion objectives in the corneal center and near the nasal or temporal ICRS. Corneal optical sections were recorded in real time without further digital processing and were reviewed frame by frame. MAIN OUTCOME MEASURES: Video frames selected from all corneal layers were evaluated qualitatively and quantitatively. RESULTS: In the central cornea, we found normal morphologic features at all layers. In peripheral sections, epithelial cells with highly reflective nuclei in the basal cell layer were observed in six of 17 eyes (35%) implanted with ICRS. We found an intact corneal nerve plexus and undisturbed corneal endothelium immediately underneath the ICRS. Around the ICRS, moderate fibrosis was seen. In one eye, linear structures in bamboo-like orientation were detected after ICRS removal in the last keratocyte layer underneath the collapsed tunnel. CONCLUSIONS: Whereas the central corneal zone appears unchanged, the corneal stroma adjacent to the ICRS displays a slight, but distinct, activation of wound healing. Epithelial cells with highly reflective nuclei in this region may be an indicator for an increased biologic stress caused by the device.     

Late bacterial keratitis after implantation of intrastromal corneal ring segments

We report a case of bacterial keratitis that occurred after implantation of intrastromal corneal ring segments (Intacs). The patient presented with decreased vision, inflammation, and stromal infiltrates localized at the extremity of an Intacs channel 3 months after surgery. Culture were positive for Clostridium perfringens and Staphylococcus epidermidis. The infiltrates progressed despite treatment with topical fortified and systemic antibiotics. The Intacs were removed. The keratitis slowly resolved, and the patient recovered a best corrected visual acuity of 20/20.     

Decision making nomogram for intrastromal corneal ring segments in keratoconus

Purpose:

To create a nomogram for the insertion of intrastromal corneal ring segments (ICRS) (Intacs^® ) in eyes with keratoconus.

Setting:

Tertiary eye care center in South India.

Materials and Methods:

This prospective, non-randomized, interventional case series used a self-designed decision-making nomogram for the selection of ICRS in keratoconus patients based on the centration of the cone, mean refractive spherical equivalent (MRSE), and mean keratometry (Km) values. The 3, 6, and 12 months clinical outcomes were compared to historical controls. Primary endpoints were improvement in uncorrected and best-corrected vision and change in the keratometric values.

Results:

Group A comprised of 52 eyes of 50 patients that followed the nomogram, while Group B comprised of 25 eyes of 23 non-nomogram historical controls matched for baseline parameters. In Group A, the uncorrected distance visual acuity (UDVA) improved from 0.16 ± 0.15 to 0.25 ± 0.16 (P < 0.001), corrected distance visual acuity (CDVA) from 0.58 ± 0.2 to 0.69 ± 0.21 (P = 0.022), MRSE from -5.41 ± 4.94 to -1.71 ± 2.88 (P < 0.001), Km from 51.77 ± 5.45 to 48.63 ± 4.37 (P < 0.001), and astigmatism reduced from 5.86 ± 2.61 to 4.91 ± 2.72 diopters (P < 0.001).In Group B, improvement in the average MRSE was from -6.44 ± 5.32 to -3.26 ± 2.82 (P < 0.013) and in the average Km from 53.64 ± 5.32 to 50.31 ± 5.02 (P < 0.001). Other parameters did not improve significantly. A statistically significant difference was present in the percentage of patients achieving a good clinical outcome between the two groups (P < 0.001; Chi-square).

Conclusion:

The nomogram provides a means to choose the appropriate ICRS, hence improving the outcome in patients with keratoconus.     

Clinical effectiveness of intrastromal corneal ring segments among keratoconus patients

AIM: To evaluate the clinical effectiveness of intrastromal corneal ring segments (ICRS) among the patients suffering from keratoconus. METHODS: A retrospective and non-comparative interventional design had been utilized on the basis of postoperative follow-up among 56 keratoconus patients. Visual acuity was significantly assessed during complete ophthalmic examination of the patients. The femtosecond laser had been used to create the corneal tunnels in 15 eyes; whereas, the corneal tunnels were created in 72 eyes mechanically. RESULTS: The ranges and standard deviations had been used to obtain results. It had been revealed through ophthalmic assessment that the mean preoperative uncorrected visual acuity observed was 1.38±0.37 logarithm of Minimal Angle of Resolution. Moreover, a significant improvement was observed postoperatively in visual acuity by 0.58±0.32 during the 4th month. The improvement was also witnessed in the 16th month by 0.48±0.30. CONCLUSION: The implantation of ICRS is an efficient and effective surgical intervention for the treatment of keratoconus. Thus, identified intervention seems to be associated with appropriate visual outcomes and safety after the development of femtosecond as well as mechanical tunnels.     

Surgically induced astigmatism after implantation of intacs intrastromal corneal ring segments

PURPOSE: To analyze surgically induced astigmatism (SIA) after implantation of Intacs intrastromal corneal ring segments. SETTING: Multicenter clinical trials in the United States. METHODS: Data from 11 investigational sites involved in the Phase II and III trials of Intacs for the United States Food and Drug Administration were retrospectively analyzed. The distribution of Intacs thicknesses implanted in 449 eyes was 0.25 mm in 148 eyes, 0.30 mm in 151 eyes, and 0.35 mm in 150 eyes. Refractive astigmatism was measured by subjective manifest refraction preoperatively and 1 week and 1, 2, 3, 6, 9, and 12 months postoperatively. The mean simple change in astigmatism and the surgically induced refractive change were determined by vector analysis. RESULTS: Mean induced astigmatism at 12 months was 0.13 diopter (D) +/- 0.52 (SD). Induced astigmatism was more frequently with the rule (44%) than against the rule (26%) or oblique (30%). Maximal mean astigmatism was 0.50 +/- 1.09 D and occurred at 7 days. Mean induced astigmatism increased with segment thickness (0.01 D, 0.17 D, and 0.21 D for the 0.25 mm, 0.30 mm, and 0.35 mm segments, respectively). Mean surgically induced refractive change in cylinder power in all eyes at 12 months by vector analysis was 0.17 D x 92. CONCLUSION: Mean SIA was not clinically meaningful 12 months after Intacs implantation.     

Clinical outcomes after intrastromal corneal ring segments reoperation in keratoconus patients

AIM:To evaluate the clinical outcomes after Ferrara intrastromal corneal ring segments (ICRS) reoperation in patients with keratoconus.RESULTS: The mean follow-up time after the reoperation was 30.5±9.7 months. The mean UCVA improved from 20/300 to 20/80 (P=0.005); the mean BCVA improved from 20/160 to 20/50 (P=0.0002), the mean keratometry reduced from 49.33±4.19D to 46.16±3.90D (P=0.0001), the mean pachymetry at the thinnest point increased from 450±42.9mm to 469±40.8mm (P=0.0001). The asphericity increased from -0.84±0.74 to -0.35±0.81 (P=0.15) and the spherical equivalent reduced from -4.64±4.87D to -3.04±3.45D (P=0.137). The changes in the asphericity and spherical equivalent were not statistically significant.CONCLUSION: Ferrara ICRS implantation showed to be a reversible and readjustable surgical procedure for keratoconus treatment. Good outcomes can be obtained even after removal, addition, reposition or exchange of ICRS.