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Biomedical subjects

Francis W Price

Publications and source records attributed to Francis W Price.

At least 19 recordsLinked to original sources

Descemet's stripping with endothelial keratoplasty: comparative outcomes with microkeratome-dissected and manually dissected donor tissue.

PURPOSE: To compare outcomes with 2 donor dissection methods for Descemet's stripping with endothelial keratoplasty (DSEK). DESIGN: Retrospective, comparative, nonrandomized case series. PARTICIPANTS: Three hundred thirty consecutive transplants, 114 with manually dissected and 216 with microkeratome-dissected donor tissue. METHODS: Donor posterior stroma/endothelium was transplanted, after stripping recipient Descemet's membrane/endothelium and dissecting the donor tissue by hand or with a microkeratome. MAIN OUTCOME MEASURES: Incidences of donor perforation and donor detachment were compared for all eyes. Visual and refractive outcomes were compared for the first 100 consecutive eyes in each group. RESULTS: Visual recovery was faster with microkeratome-dissected donor tissue, as evidenced by statistically better best spectacle-corrected visual acuity (VA) in that group 1 month after surgery (P = 0.015). Best spectacle-corrected VA was statistically comparable for the 2 groups preoperatively and 3 and 6 months postoperatively. Best spectacle-corrected VA was not correlated significantly with postoperative central corneal thickness (P = 0.25). Corneal thickness was significantly higher in the microkeratome group (690+/-77 mum, compared with 610+/-62 mum after hand dissection; P<0.0001). Mean refractive astigmatism was 1.5 diopters (D) preoperatively and 6 months postoperatively in both groups. Spherical equivalent refraction did not change in the microkeratome group (P = 0.64) but increased by 0.66 D in the hand dissection group (P = 0.0007). Methods designed to remove fluid from the donor/recipient graft interface ultimately reduced the detachment rate to <1% (1 in the last 140 cases). No donor perforations occurred in 216 microkeratome dissections, compared with 5 in 114 hand dissections (P = 0.002). CONCLUSIONS: Microkeratome dissection reduced the risk of donor tissue perforation, provided faster visual recovery after DSEK, and did not alter the refractive outcome.

Aged↗

Efficacy of topical cyclosporine 0.05% for prevention of cornea transplant rejection episodes.

PURPOSE: To assess the incidence of immunologic corneal graft rejection episodes in a prospective case series of patients treated 4 times a day with topical cyclosporine 0.05%. DESIGN: Prospective, single-center, institutional review board-approved study. PARTICIPANTS: Fifty-two cornea transplant recipients considered low risk for graft rejection. METHODS: Primary indications for transplantation were keratoconus, Fuchs' dystrophy, or nonherpetic, nonvascularized scars. Subjects completely tapered off prednisolone acetate 1% by 13 weeks after transplantation and used topical cyclosporine 0.05% 4 times a day, beginning either 1 or 10 weeks posttransplant, with use continued until 1 year posttransplant. One subgroup supplemented cyclosporine use with pulsed prednisolone acetate 1% dosing, 4 times a day for 4 days every 6 weeks. The incidence of immunologic corneal graft rejection episodes was compared with that in Fuchs' and keratoconus historical control subjects, who used topical steroids a median of 7 months after penetrating keratoplasty. MAIN OUTCOME MEASURE: Incidence of immunologic graft rejection episodes. RESULTS: Graft rejection episodes occurred earlier and with higher incidence in subjects using cyclosporine 0.05% compared with historical control subjects who used steroids for a longer period of time (P<0.0001). Cyclosporine subjects who pulse-dosed prednisolone had a significantly higher incidence of graft rejection compared with those who did not pulse steroids (P = 0.04). CONCLUSION: The results suggest that 4 times daily dosing with topical cyclosporine 0.05% is not as effective as use of topical prednisolone acetate 1% for prevention of graft rejection episodes in low-risk corneal transplants, and that periodic pulsing with corticosteroids may increase the risk of rejection episodes.

Administration, Topical↗

Descemet's stripping with endothelial keratoplasty in 200 eyes: Early challenges and techniques to enhance donor adherence.

PURPOSE: To describe early challenges and techniques to promote donor tissue adherence in Descemet's stripping with endothelial keratoplasty (DSEK). SETTING: Price Vision Group, Indianapolis, Indiana, USA. METHODS: The first 200 consecutive cases of DSEK performed by a single surgeon were analyzed retrospectively. Follow-up was 7 to 20 months for 124 eyes and 2 to 6 months for 76 eyes. The surgical technique consisted of stripping Descemet's membrane and endothelium from the recipient's central cornea and transplanting an 8.0 to 9.0 mm disc of donor endothelium and posterior stroma through a 5.0 mm incision, with sutures used only to close the incision. RESULTS: The most frequent challenge was inadequate donor attachment. Using techniques to remove fluid from the donor-recipient graft interface, the donor detachment rate in the last 64 cases was 6%, with half attributable to patient eye rubbing. Detached grafts were reattached by injecting an air bubble to press the donor against the recipient cornea. There were 7 primary graft failures, with only 1 occurring in the second 100 cases, which primarily used microkeratome-dissected donor tissue. Other complications were infrequent and included pupillary block glaucoma (1), aqueous misdirection syndrome (1), and cataract development in 2 of 27 phakic eyes. The DSEK procedure was performed safely before and after laser in situ keratomileusis (1 each). CONCLUSIONS: Early outcomes in the initial 200 consecutive DSEK procedures suggest the technique provides significant advantages over penetrating keratoplasty, including more rapid healing, more predictable refractive outcomes, and better retention of corneal strength and integrity. Although donor adherence was more challenging, DSEK was technically easier and should be less traumatic to anterior chamber structures than earlier posterior grafting techniques.

Aged↗

Endothelial keratoplasty to restore clarity to a failed penetrating graft.

PURPOSE: To describe an adaptation of endothelial keratoplasty to restore corneal clarity to a prior penetrating keratoplasty (PK) with endothelial decompensation. METHODS: A surgeon's initial 7 consecutive cases using endothelial keratoplasty for treatment of failed prior PK were retrospectively analyzed. The treated eyes had all experienced endothelial decompensation after previously having clear corneal transplants. Instead of repeating the PK, a partial-thickness donor button, composed of posterior stroma with Descemet membrane and endothelium, was grafted to the posterior surface of the failed full-thickness donor graft. In 6 of the 7 cases, the only sutures were those used to close a 5-mm scleral tunnel incision. The donor button was initially held in place with an air bubble and later attached on its own. RESULTS: In all cases, the new donor button adhered to and cleared the edema from the previous penetrating graft. Within 3 months of endothelial keratoplasty, best-corrected visual acuity had improved in 6 of the 7 cases compared with the preoperative vision. CONCLUSION: Standard PK usually takes months to years to heal sufficiently to remove sutures and provide patients with a stable refraction and a wound strong enough to withstand minor trauma. Using endothelial keratoplasty to rehabilitate a failed graft may provide faster visual recovery, a tectonically stronger eye, and a reduced period of disability compared with repeating the PK. Endothelial keratoplasty may be a particularly useful alternative for treating penetrating grafts that achieved acceptable refractive and ocular surface results but failed because of endothelial dysfunction.

Adult↗

Histology of posterior lamellar keratoplasty.

PURPOSE: To report histology of a posterior lamellar graft performed to treat clinically significant endothelial disease in a patient with Fuchs dystrophy. METHODS: A 78-year-old patient with Fuchs dystrophy underwent posterior lamellar keratoplasty (PLK), the original form of endothelial keratoplasty performed with manual lamellar dissection of the recipient and donor corneas. Eighteen months later, the patient had herpes simplex virus keratitis and graft rejection episodes. One year after the infection resolved (2.5 years after PLK), penetrating keratoplasty was performed, and the excised corneal button was examined. RESULTS: Histopathologic evaluation of the corneal button showed no discernible interface, opacity, or gapping between the anterior host stromal tissue and PLK donor tissue or any signs of significant migration of donor endothelial cells onto recipient tissue. CONCLUSION: This PLK histology showed firm attachment with no visible interface between the posterior donor and anterior host stromal tissue. Surprisingly, no significant donor endothelial cell migration was detected on adjacent recipient tissue where Descemet membrane had been excised or where endothelial cells were lost as a result of the procedure.

Aged↗

Donor descemet membrane detachment after endothelial keratoplasty.

PURPOSE: To describe histopathologic characteristics of an endothelial keratoplasty (EK) that was performed to treat a previously failed penetrating keratoplasty (PK) and in which the cornea failed to clear after partial detachment of Descemet membrane from the EK donor button. The Descemet membrane and endothelium from the PK were intentionally retained during the EK procedure. METHODS: After EK, the cornea failed to fully clear in 5 months, and a PK was performed. The removed corneal button was grossly described and routinely processed for hematoxylin-eosin (H&E) and periodic acid-Schiff (PAS) staining, with photographs taken of any pertinent findings. RESULTS: Grossly on the endothelial side, there was some adherent iris pigment delineating an off-center fold in the EK Descemet membrane, consistent with intraoperative observation of a fold across the width of the donor button and postoperative slit-lamp images showing partial detachment of Descemet membrane. Microscopic examination revealed a recipient corneal button from a prior PK centrally and EK donor button attached posteriorly. Descemet membrane was not stripped from the prior PK during EK and was intact. No endothelial cells were detected on the PK Descemet membrane. The anterior stromal surface of the EK was well apposed to the prior PK Descemet membrane, with no pseudoanterior chamber or cleft of any type noted between them. The EK Descemet membrane had a central fold, and the endothelium was markedly attenuated. CONCLUSION: The EK graft was well apposed with apparent good adherence to the recipient's prior failed PK, and early endothelial failure was attributable to partial Descemet membrane detachment.

Adult↗

Late dislocation of scleral-sutured posterior chamber intraocular lenses.

PURPOSE: To examine a recent series of late scleral-sutured posterior chamber intraocular lens (PCIOL) dislocations to identify possible causes and preventive measures. SETTING: Price Vision Group, Indianapolis, Indiana, USA. METHODS: In this retrospective non-comparative interventional case series, 5 consecutive patients received treatment for dislocated scleral-sutured PCIOLs between July 2002 and March 2004. Dislocated lenses were resutured or replaced with another scleral-sutured PCIOL. RESULTS: Dislocation of scleral-sutured PCIOLs occurred 7 to 14 years after implantation. Four dislocations were spontaneous, and 1 was precipitated by trauma. In each case, the suture affixing 1 or both haptics failed. There was no evidence that the suture had eroded through the tissue or that the knot had untied. Microscopic analysis of an explanted IOL with remnants of the suture attached showed localized degradation and cracking of the polypropylene suture material where it had been embedded in the scleral tissue. CONCLUSION: Suture-fixated PCIOLs can dislocate due to degradation of the suture material over time. The use of larger diameter (9-0 instead of 10-0) polypropylene suture material and placement of the haptic and sutures in the ciliary sulcus to promote attachment of scar tissue may enhance the long-term stability of scleral-fixated PCIOLs.

Adult↗

Effect of gatifloxacin 0.3% and moxifloxacin 0.5% ophthalmic solutions on human corneal epithelium following 2 dosing regimens.

PURPOSE: To determine whether gatifloxacin 0.3% ophthalmic solution or moxifloxacin 0.5% ophthalmic solutions are toxic to the corneal epithelium when used with 1 of 2 dosing regimens in healthy human eyes. SETTING: Price Vision Group, Indianapolis, Indiana, USA. METHODS: In this double-masked randomized fellow-eye comparison study, gatifloxacin 0.3% was instilled in 1 eye and moxifloxacin 0.5% in the other eye either 4 times a day for 7 days or hourly for 10 hours. Before and after dosing, all eyes were examined with a slitlamp and the cell layers in the central cornea were evaluated by confocal microscopy. Subject discomfort with study drop instillation was also assessed. RESULTS: There was no statistically significant increase in the incidence or severity of superficial punctuate keratitis following use of gatifloxacin 0.3% or moxifloxacin 0.5% when instilled 4 times a day for 7 days or hourly for 10 hours. Hourly use of gatifloxacin 0.3% for 10 hours resulted in a mild but statistically significant increase in conjunctival hyperemia (P = .029). Use of moxifloxacin 0.5% resulted in a small but statistically significant deterioration of the corneal epithelial surface as assessed by confocal microscopy (P = .045). The incidence of subject discomfort with study drop instillation was comparable for the 2 antibiotics (P = .67). CONCLUSION: Use of ophthalmic solutions of gatifloxacin 0.3% or moxifloxacin 0.5% did not result in clinically significant epithelial toxicity in healthy human corneas after dosing regimens of 4 times a day for 7 days or hourly for 10 hours dosing regimens.

Adult↗

Interim results of the United States investigational device study of the Ophtec capsular tension ring.

PURPOSE: To evaluate the safety and efficacy of the Ophtec capsular tension ring (CTR) in providing capsular support during and/or after cataract extraction in cases of a weak or partially broken ciliary zonule. DESIGN: Phase III multicenter, nonrandomized, investigational device study. PARTICIPANTS: Twelve investigators at 9 sites enrolled 224 subjects and placed 255 CTRs. METHODS: Capsular tension rings were placed in patients who were found to have a weakened or partially broken ciliary zonule comprising <34% of the circumference of the lens capsule. Two CTR models were evaluated, with noncompressed diameters of 12 mm and 13 mm. Patients were examined preoperatively, intraoperatively, and postoperatively at day 1 and months 1, 3, 6, and 12. MAIN OUTCOME MEASURES: Rate of successful stabilization of the capsular bag and intraocular lens (IOL) centration, complications, and adverse events. RESULTS: Interim results from this ongoing study indicate that immediately after surgery 98.8% of IOLs were centered and 1.2% of the IOLs implanted (3/251) were not centered. Subsequently, the prevalence of decentered IOLs was 1.7% (4/236) 3 months after surgery, 3.8% (8/211) 6 months after surgery, and 2.3% (4/172) 12 months after surgery. The primary complication was posterior capsular opacification, which is unlikely to be a complication of CTR insertion. Neodymium:yttrium-aluminum-garnet laser capsulotomies have been performed in 12.8% of eyes by 12 months (22/172). CONCLUSIONS: Ophtec CTR models 275 and 276 safely provided capsular support during and after cataract surgery in cases where the zonule was weak or partially broken.

Adult↗

Effect of gatifloxacin ophthalmic solution 0.3% on human corneal endothelial cell density and aqueous humor gatifloxacin concentration.

PURPOSE: To evaluate the effect of gatifloxacin ophthalmic solution 0.3% (Zymar, Allergan, Inc., Irvine, CA, USA) on corneal endothelial cell density and morphology and to measure gatifloxacin penetration into aqueous humor. METHODS: This was a single-center, open-label clinical study. Ten patients undergoing standard cataract surgery and 20 nonsurgical subjects instilled gatifloxacin 0.3% four times per day for 2 days, then every 10 min for 1 hr on the third day (the surgery day for the cataract patients). Corneal endothelial cells were counted using noncontact specular microscopy. Anterior chamber fluid was withdrawn from the surgical patients, and the gatifloxacin concentration was quantified by high-pressure liquid chromatography. RESULTS: Baseline endothelial cell counts (mean +/- SD) were 2400 +/- 442 in the surgical group and 2520 +/- 212 in the nonsurgical group. The mean differences from baseline 1 hr after the last dose of gatifloxacin 0.3% were -51 +/- 213 (p = 0.23) in the surgical group and -7 +/- 150 (p = 0.42) in the nonsurgical group. In the nonsurgical group, the mean difference from baseline 3 weeks after the last dose was 18 +/- 147 (p = 0.71). The mean concentration (+/- SD) of gatifloxacin in aqueous humor was 1.26 +/- 0.55 microg/ml. CONCLUSIONS: A preoperative, prophylactic course of gatifloxacin 0.3% ophthalmic solution did not significantly affect endothelial cell density or morphology, while meaningful drug concentration was achieved in the aqueous humor.

Administration, Topical↗

Cataract progression and treatment following posterior lamellar keratoplasty.

PURPOSE: To describe the development and treatment of cataracts following posterior lamellar keratoplasty (PLK) in phakic eyes with Fuchs' endothelial dystrophy. SETTING: Price Vision Group, Indianapolis, Indiana, USA. METHODS: A retrospective chart review was performed on 47 PLK cases performed by a single surgeon between June 2001 and December 2002 in a tertiary care setting. Four of the eyes were phakic at the time of surgery. The PLK procedure consisted of dissecting a stromal pocket across the cornea and excising a central button. Then a posterior lamellar donor button, consisting of posterior stroma, Descemet's membrane, and endothelium, was transplanted without suture fixation. RESULTS: All 4 phakic eyes that were treated with PLK developed a cataract within 1 year of transplant. The cataracts were removed with phacoemulsification through a clear corneal incision, and intraocular lenses (IOLs) were placed in all 4 eyes with no adverse effect on graft clarity. CONCLUSIONS: It is preferable to perform PLK in pseudophakic rather than phakic eyes because the manipulation involved in the procedure can induce cataract formation. Cataract surgery with placement of an IOL can be successfully performed following PLK.

Aged↗

Ophtec iris reconstruction lens United States clinical trial phase I.

PURPOSE: To determine the safety and efficacy of the Ophtec model 311 iris reconstruction lens for treatment of visual disturbances, such as glare or photophobia, related to partial or total absence of the human iris. DESIGN: Phase I multicenter, nonrandomized, investigational device study. PARTICIPANTS: Ten iris reconstruction lenses were placed in 10 subjects at 6 sites. METHODS: Iris reconstruction lenses were placed in 9 patients who had lost all or part of their iris from trauma and in 1 patient who lacked iris pigmentation due to congenital albinism. Patients were examined preoperatively, intraoperatively, and postoperatively at day 1; week 1; and months 1, 3, 6, and 12. MAIN OUTCOME MEASURES: Efficacy measures were uncorrected visual acuity (UCVA), glare, starbursts, and photophobia. Safety measures were best-corrected visual acuity (VA), surgical complications, and adverse events. RESULTS: Uncorrected VA improved in all eyes after implantation of the iris reconstruction lens. Best-corrected VA did not change significantly (P = 0.24). Postoperative photophobia was reduced in all 9 eyes that experienced moderate to severe preoperative photophobia. Likewise, postoperative glare was reduced in all 6 eyes with moderate to severe preoperative glare. There were no surgical complications. Adverse events included 2 cases of iritis and 1 case of macular edema. CONCLUSIONS: Preliminary results suggest that the Ophtec model 311 iris reconstruction lens can improve UCVA and reduce glare and photophobia in patients with partial or total absence of the iris or iris pigmentation.

Adult↗

Topical anesthesia for penetrating keratoplasty.

PURPOSE: To evaluate the use of topical anesthesia for penetrating keratoplasty (PKP) in situations where retrobulbar, peri/parabulbar, or general anesthesia are inadvisable or not readily available. METHODS: This was a retrospective analysis of a consecutive case series consisting of 8 eyes in 8 patients who had PKP with topical anesthesia between September 1995 and December 1997 in cases where retrobulbar, peri/parabulbar, or general anesthesia either could not be performed or presented too great a risk to the patient. Some cases were supplemented with small limbal injections, mild intravenous sedation (fentanyl), and/or intraocular anesthesia. In one case, intraocular 1% lidocaine was placed directly into the vitreous cavity to allow an open-sky vitrectomy. RESULTS: In all cases, PKP was completed without complications. All patients tolerated the procedure well and reported only mild discomfort. However, in 2 cases, an ACIOL was left in place because lens manipulation caused pain in the ciliary body and iris root areas. CONCLUSIONS: PKP can be performed successfully with topical anesthesia in cooperative patients who have perforated corneal ulcers, significant anticoagulation, or severe medical conditions, which make alternative forms of anesthesia more risky.

Adult↗

Efficacy of topical ketorolac tromethamine 0.4% for control of pain or discomfort associated with cataract surgery.

OBJECTIVE: To evaluate the efficacy of ketorolac 0.4% ophthalmic solution for control of pain and discomfort associated with cataract surgery. METHODS: This was a single-center, double-masked, randomized, fellow-eye placebo-controlled clinical study of 25 patients (mean age 72 years; 76% female) requiring bilateral cataract surgery. Patients received either ketorolac tromethamine 0.4% ophthalmic solution (Acular LS *) or placebo, 1 drop QID for 3 days prior to and 1 day following phacoemulsification and intraocular lens implantation on their first eye, and the other treatment for surgery on the second, fellow eye 1 week-4 weeks later. The physician rated patient cooperation and ocular pain or discomfort during surgery, and patients rated ocular pain or discomfort immediately and 24 h after surgery. RESULTS: Patients reported significantly less ocular pain during the 24 h following surgery when treated with ketorolac 0.4% than with placebo (p = 0.02). Ocular pain was reported for only a single ketorolac 0.4%-treated eye (4%) during that period, compared with 39% of placebo-treated eyes (p = 0.004). No significant differences between eyes treated with ketorolac 0.4% and placebo were observed in patient cooperation, and ocular pain or discomfort during or immediately after surgery. No adverse events occurred during the study. LIMITATIONS: Evaluation of pain is subjective, and the severity of pain experienced in the control, vehicle-treated eyes was low. CONCLUSIONS: The reduction in pain associated with cataract surgery afforded by ophthalmic ketorolac 0.4%, together with its favorable safety profile, make it an important tool to help surgeons meet the high expectations of today's cataract and refractive surgery patients.

Administration, Topical↗

Risk factors for various causes of failure in initial corneal grafts.

OBJECTIVE: To determine the risk factors for specific causes of initial corneal graft failure. METHODS: This study analyzed corneal graft survival rates in a longitudinal noncomparative case series of 3992 consecutive penetrating keratoplasties performed at a single large referral center. Regrafts (n = 352) were excluded from the analysis of risk factors for initial graft failure. Data were collected retrospectively from August 1, 1982, through December 31, 1986, and prospectively from January 1, 1987, through August 31, 1996. Patients were examined preoperatively, at 1, 3, 6, 9, 12, 18, and 24 months posttransplantation, and annually thereafter. Potential risk factors were evaluated individually by Kaplan-Meier survival analysis. Cox proportional hazards regression modeling was then used to investigate the impact of each independent variable, adjusted for the confounding influence of the other independent variables. RESULTS: The use of topical glaucoma medications was a significant risk factor for corneal graft failure by 3 major causes: rejection, endothelial decompensation without a documented immunologic reaction, and ocular surface disease. Deep stromal vascularization was an independent risk factor for rejection failure. Diabetes mellitus, peripheral anterior synechiae, recipient race, and small trephination size were significant risk factors for endothelial failure. CONCLUSION: Independent risk factors differentially impact specific causes of corneal graft failure.

Adolescent↗