[ISO 9001-2000 certification for refractive laser treatment]. / Certification ISO 9001-2000 des traitements réfractifs par laser cornéen.

PURPOSE: To obtain ISO 9001-2000 certification for laser corneal refractive treatment, never before sought in Europe. MATERIAL AND METHODS: The consulting firm Veritas led the certification process with the clinic's staff manager. This ISO norm is dedicated to the implementation of a quality management system. We assessed and optimized all necessary resources, evaluating customer satisfaction using patient and referring-physician surveys. We started quality rounds including surgeons, nurses, and technicians. Based on this preparation, we redefined and explained all processes including staff responsibilities and necessary resources in the quality manual. The procedure lasted 14 months with substantial involvement on the part of the management. RESULTS: Unconditional ISO 9001-2000 certification was granted by the independent audit firm, BVQI, in december 2003 for refractive laser treatment. CONCLUSION: The 2000 version of the new ISO 9001-2000 seeks to meet the demand for improving health care delivery in this field, most particularly by establishing a clear procedural orientation. Such certification enhances team work, stabilizes methodologies, and reinforces cohesion and self-audit. Patients notice that the center follows a consistent quality policy and are assured that the clinic respects rules and regulations. Certification is an advantageous alternative when accreditation cannot be considered. Our article discusses the steps taken in upper management, quality management, procedural guidance, as well as customer and staff counselling. It also discusses the project's cost/benefit ratio for the organization.

Effect of growth factors on collagen lattice contraction by human keratocytes.

A three-dimensional gel contraction model was used to evaluate interactions between human keratocytes and different kinds of collagen in the presence or absence of various growth factors. Bovine collagen type I or human placental copolymerized collagen type I/III was used to create the lattices. Normal keratocytes from neonatal, aged, and insulin-dependent diabetic donors, as well as abnormal keratocytes from a donor with macular corneal dystrophy, were cultured. Growth factors included epidermal growth factor (EGF), basic fibroblastic growth factor (FGF), insulin-like growth factor (IGF-I), and platelet-derived growth factor homodimer beta beta (PDGF). Gel area and optical transmittance were determined from computerized measurements. Dose-response experiments (0.01-100 ng/ml) demonstrated that PDGF at 10 ng/ml (P less than 0.005) and EGF at 1 and 10 ng/ml (P less than 0.0001) were the most effective in promoting gel contraction, compared to IGF-I and FGF. Comparison of cell strains revealed different dose-response profiles. Cells from insulin-dependent diabetics and cells from a donor with macular dystrophy contracted lattices more rapidly than cells from normal neonates (P less than 0.0001). Lattices of copolymerized human collagen type III/I demonstrated significantly reduced contraction rates (P less than 0.0001) and increased optical transmittance, compared to bovine collagen type I lattices. Ultrastructural studies revealed that keratocytes extend processes to form a network within the collagen lattice. Specialized intercellular junctional complexes were observed by transmission electron microscopy. This model provides a useful in vitro corneal stroma-equivalent for the study of keratocyte, extracellular matrix, and growth factor interactions.

Matrix metalloproteinases in epithelia from human recurrent corneal erosion.

PURPOSE: To assay for the presence of matrix metalloproteinases (MMPs) in human corneal epithelium affected by recurrent erosion compared with that in normal corneal epithelium. METHODS: Corneal epithelial debridement samples were obtained from 13 patients with recurrent epithelial erosion. For control specimens, epithelia were obtained from healthy patients undergoing photorefractive keratectomy. Zymography was performed on all samples to identify MMPs. Immunolocalization of MMP-2, laminin, and collagen type VII was determined in two samples with human recurrent epithelial erosion and compared with that in control epithelium. RESULTS: Twelve of 13 erosion samples showed MMP-2 enzymatic activity; one of the 12 also showed MMP-9 activity. Only one erosion sample showed no MMP enzymatic activity. All normal control specimens were negative for MMP. Immunohistochemical analysis of two recurrent erosion samples showed MMP-2 presence in basal cells, whereas, in normal epithelium it was not detected. One sample with epithelial erosion showed laminin localization in basal epithelial cells and basal lamina. Type VII collagen localized in basal epithelial cells only in this sample. A second erosion sample showed localization of laminin and type VII collagen in basal epithelial cells only. Normal corneal epithelium showed presence of laminin and type VII collagen in basal epithelium and basal lamina. CONCLUSIONS: Matrix metalloproteinase-2 expression is upregulated in human epithelia affected by recurrent erosion compared with that in normal control samples. Immunolocalization studies suggest that this enzyme is concentrated in basal epithelial cells where it may play an important role in degradation of the epithelial anchoring system and the recurrent epithelial slippage and erosion observed in these patients.

Effects of scleral reinforcement on the elongation of growing cat eyes.

OBJECTIVE: We investigated the effect of scleral reinforcement on ocular elongation in the rapidly growing eyes of juvenile cats. METHODS: Bands made from donor sclera or expanded polytetrafluoroethylene were used to reinforce one eye of each animal; contralateral eyes underwent sham surgery. RESULTS: During 5 months of follow-up, normal intraocular pressures implied normal functioning of angle structures. A-scan on the central axis showed no difference in globe lengths. Direct physical measurements of the posterior aspect of the globe at enucleation revealed significant decreases in off-center lengthening where reinforcement was present compared with unreinforced areas in the same eyes and in the contralateral unbanded eyes. Venous beading in fundus photographs of three eyes suggested impairment of venous outflow. CONCLUSIONS: Scleral reinforcement appears to control expansion of the growing cat eye to a limited extent, but the effects on vision and retinal perfusion require further investigation.

PMMA model of steep central islands induced by excimer laser photorefractive keratectomy.

We designed a polymethyl methacrylate (PMMA) model of refractive steep central islands (CIs) induced by PRK. A standardized photorefractive ablation procedure was performed using seven different excimer lasers on test PMMA specimens including 70 flat plates and 98 convex contact lenses. The resulting surface was analyzed by high-resolution confocal microscopy and computerized videokeratoscopy using both TMS-1 and CAS-2000 systems. A total of 50 (54.9%) CIs were observed using computerized videokeratoscopy. The rate of occurrence of CIs was significantly reduced by shock wave absorption (P = 0.0001), aspiration of fumes (P = 0.0044), and smaller diameter ablation (P = 0.0296). The diameter of the CIIs was significantly increased for broad-beam mode ablation (P = 0.016) and for larger ablation zones, (P = 0.042). The refractive power of CIs was significantly increased in the absence of a shock wave absorption system (P = 0.001). Only 20 (40%) of the CIs detected by the TMS-1 device were identified on CAS-2000 at a 0.5 diopter (D) scale resolution level. Shock wave induced deformation and subsequent dynamic alteration of convection forces applied to emitted particles may be the primary mechanism underlying the formation of CIs after PRK, regardless of any biological response of the ablated tissue. Reported rates and characteristics of CIs may largely depend upon the specific design of videokeratoscopes.

Ultrasound biomicroscopy of Baikoff anterior chamber phakic intraocular lenses.

BACKGROUND: The purpose of the study was to analyze qualitatively and quantitatively anatomic relationships of anterior chamber Baikoff phakic intraocular lenses (IOL) to the cornea, angle, iris, and lens in myopic eyes. METHODS: Thirteen phakic myopic eyes (-9.00 to -15.00 diopters) corrected by minus power, angle-supported, anterior chamber intraocular lenses of the ZB5M style (Chiron-Domilens), with a mean follow-up of 25 months (range 18 to 36 months), were examined clinically and by ultrasound biomicroscopy. RESULTS: The mean distance (+/- SD) between the central cornea and the IOL was 2.05 +/- 0.18 mm (range 1.8 to 2.47 mm); mean distance between the corneal periphery and the IOL was 1.56 +/- 0.17 mm (range 1.33 to 1.95 mm); and the mean distance between the IOL and the lens was 0.58 +/- 0.12 mm (range 0.48 to 0.81 mm). IOL footplates seemed to be correctly positioned in the angle in all eyes. We observed no goniosynechiae. In six eyes, we found localized posterior indentation of the iris caused by the haptics. Four of these six eyes exhibited oval pupils associated with an oversized IOL. CONCLUSIONS: High frequency ultrasound biomicroscopy can define anatomic relationships of anterior chamber phakic IOLs, and help analyze the mechanisms of corneal and iris complications.

B-mode-guided vector-A-mode versus A-mode biometry to determine axial length and intraocular lens power.

PURPOSE: To compare prospectively the reproducibility and accuracy of B-mode-guided biometry with those of A-scan biometry using a conventional A-mode probe to calculate intraocular lens (IOL) power. SETTING: Department of Ophthalmology, Hôtel-Dieu de Paris, France. METHODS: The axial length (AL) in 87 eyes of 72 candidates for cataract surgery was determined by B-mode-guided vector-A-mode and A-mode biometry using an Ophthascan S Ultrasound imager. Patients were assigned to one of two groups based on the B-mode biometry: nonmyopic (AL < 24.5 mm; n = 54) or myopic (AL > 24.5 mm; n = 33). Postoperative refractive results were compared with attempted values. RESULTS: Mean AL variance was significantly greater when using the A-mode than the B-mode: 0.157 mm +/- 0.260 (SD) versus 0.015 +/- 0.018 mm in the myopic group (P < .001) and 0.024 +/- 0.024 +/- 0.045 versus 0.009 +/- 0.011 mm in the nonmyopic group (P < .001). More eyes having B-mode biometry achieved a final refraction within +/- 0.50 diopter (D) of the attempted refraction (63 and 43%, respectively; P < .05). No deviation greater than 1.60 D was observed with the B-mode in the myopic or nonmyopic group. Three cases with a such a deviation (up to 2.24 D) would have been observed had A-mode-based biometry been chosen for the IOL power calculation. In the myopic group, attempted postoperative refraction was within +/- 0.50 D in 78% of eyes having B-mode biometry compared with 65% having A-mode. This difference was not statistically significant. CONCLUSION> These results suggest that the reproducibility and accuracy of AL measurements are significantly better with B-mode-guided A-mode biometry than with A-mode biometry in myopic and nonmyopic eyes.

[Effect of recombinant human basic fibroblast growth factor (rh-bFGF) on wound healing of the corneal epithelium]. / Effekt von rekombinatem humanem basischem Fibroblastenwachstumsfaktor (rh-bFGF) auf die Wundheilung des Hornhautepithels.

Prior to a possible clinical trial in humans, we studied the wound-healing effect of RH-bFGF in vivo. Healing-rate measurements on 24 deepithelialized rabbit corneas were performed by means of computer-assisted image analysis. A significantly increased healing rate (P = 0.004) was revealed for the 200 ng FGF treated group (rate 1.57 mm2/h) compared to the control group (1.12 mm2/h). To assess the long-term (side) effects of FGF (50 ng topically applied, 2 times daily), 7 rabbits were involved in a model with repeated epithelial scraping of an anterior keratectomy wound (performed with Draeger's rotokeratom to a depth of 0.15 mm). Light and transmission electron micrographs of treated corneas showed an increased fibrogenesis in the anterior stroma with more pronounced activation of keratocytes. No evidence of abnormal neovascularization or inflammation was observed when compared to control corneas. We suggest that topical RH-bFGF promotes corneal wound healing with virtually no detectable adverse reactions. These results seem to be of considerable interest for the possible therapeutic use of rh-bFGF in patients with superficial corneal epithelial lesions.

A prospective randomized trial of topical soluble 0.1% indomethacin versus 0.1% diclofenac versus placebo for the control of pain following excimer laser photorefractive keratectomy.

BACKGROUND AND OBJECTIVE: To compare the safety and efficacy of topical nonsteroidal antiinflammatory drugs (NSAIDs) for the control of pain after excimer laser photorefractive keratectomy (PRK). PATIENTS AND METHODS: One hundred twenty informed patients were enrolled in a double-masked, randomized, comparative study and assigned to either 0.1% indomethacin, 0.1% diclofenac, or placebo treatment. Subjective postoperative pain, symptoms, re-epithelialization rate, and systemic medications were monitored for 2 days following photoablation. RESULTS: Compared with the placebo, 0.1% indomethacin solution significantly reduced pain on the day of surgery (D0) (P < .05), whereas 0.1% diclofenac did not reach a significant level (P = .46). At D0, analgesic intake by the oral route was significantly greater in the placebo group (P < .05). Severe photophobia was significantly less frequent in the group treated with 0.1% indomethacin (P < .05). Corneal wound healing was significantly delayed in the patients treated with 0.1% diclofenac at D2 as compared with other groups (P = .04). CONCLUSION: Topical 0.1% indomethacin solution helps control the pain induced by excimer laser photoablation of the cornea without any detrimental effect to the corneal epithelial wound healing.

[Posterior scleral reinforcement surgery]. / Chirurgie du renforcement scléral postérieur.

UNLABELLED: Scleral reinforcement is proposed to stabilize the visual acuity in patients with macular myopic staphyloma. Although many patients have been treated, this procedure is still debated. PURPOSE: Evaluation of the feasibility of scleral reinforcement and the operative risk of this procedure. PATIENTS AND METHODS: Patients were eligible for this prospective study patients with a clinical history of visual loss, staphyloma concerning the macular area associated with atrophic lesion and or lacquer cracks. Sixteen eyes in 13 successive patients have been operated on with a single band of PTFE. RESULTS: At the last examination, visual acuity was unchanged for 14 cases. In one case, an improvement of the vision was related to the disappearing of a macular detachment by shortening of the axial length. In one case, vision decline was associated with inadequate band position. Diplopia occurred in 2 cases. A choroidal detachment, and a vitreous haemorrhage disappeared without sequelae. CONCLUSION: An accurate technique is necessary to avoid operative risk. Further long term studies are needed to assess the benefit of scleral reinforcement.

[Computerized video-keratoscopic analysis and cataract surgery by phacoemulsification. Predictive calculation of the power of the intraocular implant]. / Analyse vidéokératoscopique informatisée et chirurgie de la cataracte par phacoémulsification. Calcul prédictif de la puissance de l'implant intraoculaire.

PURPOSE: The authors present the results of a prospective study of 125 consecutive cases of phacoemulsification, performed by a single surgeon, to assess the benefit of computerised videokeratoscopy for the improvement of the predictive calculation of the power of intraocular lenses (IOL). METHODS: Preoperative keratometry was determined by means of 3 concurrent techniques, including automated kerato-refractometry (AKR 2000, Nidek) and videokeratoscopy by TMS-1 (Tomey) and CAS-1 (EyeSys). The results of the IOL calculation by these 3 methods was compared postoperatively to the power of the actual IOL yielding emmetropia as calculated by the optical method based on the postop, refraction at the various time-points. RESULTS: Simulated values obtained with videokeratoscopy significantly reduced the refractive error at 1 postop, week (p = 0.001), one month (p = 0.002) and 3 months (p = 0.002) for the CAS1 and at 3 months (p = 0.002) for the TMS1, as compared to values obtained with conventional automated keratometry. The refractive error was significantly reduced with the CAS1 at one month (p = 0.001) and 3 months (p = 0.019) as compared to TMS1. CONCLUSION: The determination of the anterior curvature of the entrance pupil by videokeratoscopy significantly improves the predictive calculation of the IOL power.

[Internal transient palpebral inclusion following dacryocystorhinostomy]. / Inocclusion palpébrale interne transitoire après dacryocystorhinostomie.

The authors report two cases of postoperative lagophthalmos immediately following ab externo dacrycystorhinostomy (DCR). Two female patients, aged 67 and 62 years, underwent under general analgesia for chronic dacryocystitis with mucocele. An inferior surgical approach, sparing the inner canthal ligament was chosen in both cases. Lagophthalmos was observed on the operated side on the first postoperative day. Normal lid occlusion was present on the contralateral side. Impairement of palpebral occlusion was predominant in the nasal portion of the lid fissure. Upon voluntary and reflex blinking, a reduction in the downward movement of the superior lid was observed. This reduction was not as apparent when the patients were asked to produce a forced blink. Lagophthalmos disappeared progressively over 3 postoperative months in both cases. Neither epiphora nor any corneal complications were observed. Lagophthalmos following DCR via an inferior approach is a previously unreported complication and may be related to the disinsertion of the nasal portion of the orbicularis muscle and periosteum at the time of periosteal cleavage. Recovery of normal lid function may be due to reattachment of the periosteum.

[Transient internal palpebral inocclusion after dacryocystorhinostomy]. / Inocclusion palpébrale interne transitoire après dacryocystorhinostomie.

The authors report two cases of postoperative lagophthalmos immediately following ab externo dacryocystorhinostomy (DCR). Two female patients, aged 67 and 62 years, underwent under general analgesia for chronic dacryocystitis with mucocele. An inferior surgical approach, sparing the inner canthal ligament was chosen in both cases.

[Characteristics of corneal topography in candidates for surgery for myopia]. / Caractéristiques de la topographie cornéenne des candidats à la chirurgie de la myopie.

INTRODUCTION: Videokeratography analyses the corneal anterior topography. It is necessary in refractive surgery to estimate the anatomical effect of the surgery and to eliminate early Keratoconus. METHODOLOGY: Corneal anterior topography was studied on 70 consecutive patients (140 eyes) candidates for low myopia surgery (-1 to -6); 87 eyes were wearing regularly contact lenses. With the topographic analysis machine of EYESYS compagny, keratometry (Km) at 3 mm, astigmatism (delta K) at 3 mm, I-S value at 3 mm and 5 mm according to Rabinowitz method were measured in each eye. RESULTS: The average keratometry was 43.50 +/- 1.87 D. The average astigmatism was 0.909 +/- 0.75 D. 51 eyes presented an asymmetric corneal and among them 32 ware contact lenses regularly; 8 eyes out of 140 (6%) presented the association of an high central Keratometry value (> or = 47 D) and corneal asymmetry (I-S > 0.5 value). COMMENTS: The incidence of Keratoconus is higher in a candidate population for refractive surgery by self-selection. Its frequency is difficult to evaluate accurately because of the present limits for the diagnostic measures. In this population, it seems to represent about 6%. CONCLUSION: The videokeratography before refractive surgery is necessary to reveal corneal anterior topography abnormalities and to eliminate early Keratoconus.

[Reis-Buckler dystrophy: therapeutic photo-ablation with the excimer laser]. / Dystrophie de Reis-Buckler: photoablation thérapeutique au laser excimer.

PURPOSE: Reis-Buckler's corneal dystrophy consist of superficial reticulated opacities with recurring attacks of corneal erosion. Lamellar and penetrating keratoplasties were the traditional surgical means of improving recurrent erosions and vision but the dystrophy recurs following surgery. Phototherapeutic keratectomy (PTK) is now the standard method of managing this anterior corneal disease when intervention is required. MATERIAL AND METHODS: We have treated ten eyes with Reis-Buckler's dystrophy using Excimer laser PTK. RESULTS: All of patients achieved visual improvement (preoperative corrected visual acuity: average 0.3 +/- 0.2 SD, postoperative at one month 0.6 +/- 0.3 SD and 0.7 +/- 0.2 SD at one year. The refractive shift changed from a spherical equivalent of -0.92 D to a postoperative refraction of +1.80 D at one month and +1.65 D at one year.

[Phototherapeutic keratectomy in the treatment of Groenouw's type I corneal dystrophy]. / La photokératectomie thérapeutique dans le traitement de la dystrophie de Groenouw I.

PURPOSE: This study was designed to investigate the therapeutic potential of phototherapeutic keratectomy (PTK) for the treatment of corneal granular dystrophy. PATIENTS AND METHODS: PTK was performed with the Excimed UV 200, (Summit Technology, Inc) on a series of 27 eyes of 22 patients with corneal granular dystrophy. Mean patients' age was 34.6 years. The mean follow-up period was 31 months (ranged from 6 to 52 months). The changes in best corrected visual acuity and spherical equivalent were evaluated at 6, 12, 18 and 24 months. RESULTS: All of patients achieved visual improvement. Mean preoperative best corrected visual acuity (BCVA) was 20/100 and mean postoperative BCVA was 20/30 at one year. The mean hyperopic shift caused by tissue ablation was +/- 2.8 D after one year. CONCLUSION: Corneal grafting was the standard treatment for visually disabling granular dystrophy, but PTK has significant advantages over this procedure and must now be the standard method of managing corneal granular dystrophy when intervention is required.