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Biomedical subjects

Eric D Donnenfeld

Publications and source records attributed to Eric D Donnenfeld.

At least 19 recordsLinked to original sources

Comparative clinical trial of ultrasound phacoemulsification with and without the WhiteStar system.

PURPOSE: To compare the postoperative outcomes of cataract surgery performed with the Sovereign 4.0 system or the Sovereign system with WhiteStar power modulation. SETTING: Ambulatory surgery centers at 4 sites in the United States. METHODS: This was a 3-month, open-label, randomized, parallel-group comparative clinical trial in patients with visually interfering cataract. Surgeons used the divide-and-conquer phacoemulsification technique for nuclear removal. An intraocular lens was implanted using the recommended insertion system. Primary operative outcome measures were equivalent phaco time (EPT), percentage of phaco power, amount of balanced salt solution used, and surgical complications. Patients were seen 1 day and 3 months after surgery. Postoperative outcome measures were the change in endothelial cell count from the preoperative visit to 3 months, corneal clarity, inflammation, and corneal thickness. RESULTS: The Sovereign with WhiteStar group had 48 patients and the Sovereign 4.0 group, 49 patients. Mean EPT and mean percentage of power were significantly lower in the Sovereign with WhiteStar group. Mean EPT was 6.67 seconds +/- 8.2 (SD) in the Sovereign with WhiteStar group and 8.59 +/- 9.3 seconds (P = .01) in the Sovereign 4.0 group. Mean percentage of phaco power was 6.41% +/- 3.3% in the Sovereign with WhiteStar group and 8.51% +/- 4.9% in the Sovereign 4.0 group (P = .01). The Sovereign with WhiteStar group lost significantly fewer endothelial cells (-319.6 +/- 634.2 cells/mm(2)) than the Sovereign 4.0 group (-430.3 +/- 594.6 cells/mm(2)) (P = .01). Corneal clarity, cells and flare, and pachymetry were comparable with the exception of the 3-month visit. The mean change in baseline central pachymetry showed significantly less corneal thickening in the Sovereign with WhiteStar group. CONCLUSIONS: The Sovereign with WhiteStar power modulation system provides effective lens removal at lower levels of phaco power and ultrasound energy than the Sovereign 4.0 system. Lower ultrasound levels may reduce the risk for endothelial cell loss during phacoemulsification.

Cell Count↗

Preoperative ketorolac tromethamine 0.4% in phacoemulsification outcomes: pharmacokinetic-response curve.

PURPOSE: To assess the clinical benefit, relative efficacy, and pharmacokinetic-response curve of preoperative and postoperative ketorolac tromethamine 0.4% (Acular LS) to improve outcomes during and after cataract surgery. SETTING: Private clinical practice. METHODS: One hundred patients were randomized in a double-masked fashion to 4 groups of 25 to receive ketorolac for 3 days, 1 day, or 1 hour or a placebo before phacoemulsification. All treatment groups received ketorolac 0.4% for 3 weeks postoperatively; the placebo group received vehicle. Outcomes measures were preservation of preoperative mydriasis, phacoemulsification time and energy, operative time, corneal clarity, endothelial cell counts, postoperative inflammation, intraoperative and postoperative discomfort, complications, and incidence of clinically significant cystoid macular edema (CME). RESULTS: Maintenance of pupil size with 3-day ketorolac dosing was significantly better than with 1-day dosing (P<.01), which was significantly better than with 1-hour or placebo dosing (P<.01). Both 3-day and 1-day dosing were superior to 1-hour or placebo dosing. No patient receiving ketorolac 0.4% for 1 or 3 days developed CME compared with 12% of patients in the control (placebo) group and 4% in the 1-hour group. Three-day and 1-day dosing of ketorolac reduced surgical time, phacoemulsification time and energy, and endothelial cell loss and improved visual acuity in the immediate postoperative period compared with 1-hour predosing and the placebo (P<.05). CONCLUSION: The preoperative use of ketorolac tromethamine 0.4% for 3 days followed by 1-day of predosing provided optimum efficacy and superior outcomes relative to 1-hour pretreatment and a placebo.

Aged↗

A comparison of gatifloxacin to ciprofloxacin in the prophylaxis of Streptococcus pneumoniae in rabbits in a LASIK model.

PURPOSE: To investigate the efficacy of the fourth-generation fluoroquinolone, gatifloxacin 0.3%, compared to ciprofloxacin 0.3%, in preventing Streptococcus pneumoniae keratitis in a rabbit laser in situ keratomileusis (LASIK) model. METHODS: Twelve albino rabbits had bilateral lamellar flaps created. Group A (eight eyes) was given gatifloxacin 0.3%; group B (eight eyes) was given ciprofloxacin 0.3%; and group C (eight eyes) served as the controls. Groups A and B received one drop of antibiotic 20 minutes before the creation of the lamellar flap, at the conclusion of flap formation, and four times per day for 3 days. All corneas were inoculated with 0.1 mL of 4 x 10 organisms/mL of S. pneumoniae immediately after flap formation. On day 3, all corneas were examined and cultured. RESULTS: Group A (gatifloxacin) had no infiltrates and three areas of 1-mm central corneal haze. On day 3, one of eight corneas had a positive culture. Group B (ciprofloxacin) had seven infiltrates, including one perforation, and six of eight corneas had positive cultures. Group C (control) had eight corneal infiltrates, and all eight corneas had positive cultures. The data show a statistically significant difference between gatifloxacin and ciprofloxacin and gatifloxacin and control for mean infiltrate size and mean culture scores. CONCLUSIONS: The fourth-generation fluoroquinolone, topical gatifloxacin 0.3%, is superior to topical ciprofloxacin 0.3% for prophylaxis against a clinical isolate of S. pneumoniae in a rabbit LASIK model.

Animals↗

Modified intracorneal ring segment implantations (INTACS) for the management of moderate to advanced keratoconus: efficacy and complications.

PURPOSE: To evaluate the safety and efficacy of modified intracorneal ring segment implantation (INTACS) in the management of moderate and advanced keratoconus (KCN). METHODS: A modified procedure of intracorneal ring segment (INTACS) implantation was performed in eyes with moderate to advanced keratoconus that were intolerant to contact lens or spectacle correction. The main outcome measures were uncorrected visual acuity (UCVA), best spectacle corrected visual acuity (BSCVA), refraction, and keratometry. The preoperative values were compared with the values 6 and 12 months postoperatively. RESULTS: Implantation was performed on 20 eyes of 15 patients; 9 were female and 6 were male. The mean age was 30.2 years (SD +/- 5.44; range, 23-40). At the 6-month follow-up, UCVA improved from 20/154 (SD +/- 0.11) preoperatively to 20/28 (SD +/- 0.21) postoperatively (P < 0.05); BCSVA improved from 20/37 (SD +/- 0.21) preoperatively to 20/22 (SD +/- 0.13) postoperatively (P < 0.05). Spherical refractive error improved from -3.38 D (SD +/- 3.12) to -1.15 D (SD +/- 1.84); cylindrical refractive error improved from -3.75 (SD +/- 2.04) preoperatively to -1.21 (SD +/- 0.84) postoperatively (P < 0.05); average keratometry decreased from 49.50 D (SD +/- 1.64) preoperatively to 46.35 D (SD +/- 1.50) postoperatively. The changes remained stable to the 12-month follow-up. There was 1 case of anterior chamber perforation. There were 6 eyes that had ring exposure secondary to corneal thinning over the implants 3-6 months postoperatively, and a dense corneal infiltrate developed in 1 patient at 7 months postoperatively. CONCLUSIONS: The procedure appears to be effective in improving UCVA and BSCVA of patients with clinical keratoconus. In our small study group, however, there were significant (6/20) postoperative problems with regards to thinning and ring exposure.

Adult↗

Efficacy of commercially available topical cyclosporine A 0.05% in the treatment of meibomian gland dysfunction.

OBJECTIVE: To investigate the efficacy of topical cyclosporine A 0.05% (tCsA) (Restasis, Allergan Pharmaceuticals) in the treatment of meibomian gland dysfunction (posterior blepharitis). METHODS: Thirty-three patients with symptomatic meibomian gland dysfunction were randomized in a prospective study to either tCsA or placebo (Refresh Plus preservative-free artificial tears), 2 times daily for 3 months. They were evaluated at baseline and at 1, 2, and 3 months for subjective symptoms and objective signs including meibomian gland inclusions, lid margin vascular injection, tarsal telangiectasis, fluorescein staining, tear breakup time, and Schirmer scores. RESULTS: Twenty-six patients completed the study. All patients were tested for ocular symptoms, lid margin vascularity, tarsal telangiectasis, meibomian gland inclusions, tear breakup time, and fluorescein staining. At the 3-month visit, the tCsA group showed a greater improvement in ocular symptoms than the placebo group, but this difference was not statistically significant. At the 3-month visit, several objective examination findings were statistically significantly (P < 0.05) improved in the tCsA group compared with the placebo group. These differences included lid margin vascular injection, tarsal telangiectasis, and fluorescein staining. The most significant finding (P = 0.001) was the greater decrease in the number of meibomian gland inclusions in the tCsA group compared with the placebo group. CONCLUSIONS: Topical CsA may be helpful in the treatment of meibomian gland dysfunction (posterior blepharitis). Topical CsA did not induce an improvement in the symptoms, but it did decrease the number of meibomian gland inclusions in patients with meibomian gland dysfunction.

Adult↗

Pyogenic granuloma formation following placement of the Medennium SmartPLUG punctum plug.

PURPOSE: To report a complication, not previously described, of the Medennium SmartPLUG, which is a new punctal plug with a novel design. METHODS: Two case reports are detailed, including clinical and pathologic photographs. RESULTS: Case 1 is a 58-year-old woman with Sjögren syndrome. Nearly 2 years following placement of a SmartPLUG in her right lower canaliculus, the patient presented with an erythematous, papillomatous growth overlying her punctum. Biopsy demonstrated pyogenic granuloma. Case 2 is a 62-year-old woman with dry eye. Exactly 2 years after a SmartPLUG was place in her right lower canaliculus, she also developed a pyogenic granuloma. After irrigation to remove the plug, the growth decreased in size. CONCLUSION: Pyogenic granuloma can develop as a late complication of the Medennium SmartPLUG punctum plug.

Dry Eye Syndromes↗

An update on the use of ophthalmic ketorolac tromethamine 0.4%.

Ketorolac tromethamine 0.4% ophthalmic solution, a recent reformulation of the original ketorolac tromethamine 0.5% solution, is indicated for the reduction of ocular pain and burning/stinging following cataract and refractive surgery. Studies have demonstrated that ketorolac tromethamine 0.4% has equivalent efficacy to ketorolac tromethamine 0.5% in reducing postsurgical inflammation and controlling pain. Several studies have demonstrated that, as well as reducing pain and ocular inflammation, ketorolac tromethamine 0.4% effectively treats cystoid macular oedema, inhibits miosis and may prevent cystoid macular oedema when used both pre- and postoperatively. Ketorolac tromethamine 0.4% is a versatile agent and is effective when used as either monotherapy or as an adjunct therapy to steroids.

Administration, Topical↗

Slitlamp biomicroscopy of the tear film of patients using topical Restasis and Refresh Endura.

We describe a technique in which slitlamp biomicroscopy is performed to evaluate eyes in patients using a topical dry-eye agent; ie, topical cyclosporine A ophthalmic emulsion 0.05% (Restasis) or glycerin 1%-polysorbate 80 1% (Refresh Endura). Both are delivered in an oil-emulsion formulation. We also describe a previously unreported physical finding in the tear film of these patients. The examination technique can help confirm patient compliance and the tear-film stability of the 2 agents.

Administration, Topical↗

Penetration of topically applied gatifloxacin 0.3%, moxifloxacin 0.5%, and ciprofloxacin 0.3% into the aqueous humor.

PURPOSE: To investigate the aqueous penetration of 3 commercially available ophthalmic fluoroquinolones. DESIGN: Prospective, double-masked, clinical study. PARTICIPANTS: Fifty-two eyes of 52 patients. INTERVENTION: Fifty-two patients undergoing cataract surgery were given preoperative topical gatifloxacin 0.3% (Zymar), moxifloxacin 0.5% (Vigamox), or ciprofloxacin 0.3% (Ciloxan). The patients were instructed to use their antibiotic drops 4 times a day for 3 days before surgery. On the day of surgery, patients were given their assigned antibiotic every 15 minutes for 3 doses, 1 hour before their procedure. At the time of surgery, 0.1 ml of aqueous fluid was aspirated from the anterior chamber with an air cannula needle attached to a tuberculin syringe. The aspirate was immediately stored at -70 degrees C. MAIN OUTCOME MEASURE: Fluoroquinolone concentrations were determined by reverse-phase high-pressure liquid chromatography assay technique with ultraviolet detection at a wavelength of 275 nm. RESULTS: Mean aqueous concentration of gatifloxacin in 16 eyes was 0.63 microg/ml (standard deviation [SD], 0.30), moxifloxacin in 14 eyes was 1.31 microg/ml (SD, 0.46), and the mean concentration of ciprofloxacin in 22 eyes was 0.15 microg/ml (SD, 0.11). CONCLUSIONS: Both moxifloxacin (P<0.001) and gatifloxacin (P<0.005) penetrated the aqueous humor at significantly higher levels than ciprofloxacin. Moxifloxacin penetrated into the aqueous humor at significantly higher levels than gatifloxacin (P<0.05). The anterior chamber levels of moxifloxacin and gatifloxacin may be due to the difference in antibiotic concentration.

Aged↗

Childhood onset of pterygia in twins.

PURPOSE: To report a case of childhood onset of pterygia in twins. METHODS: Twelve-year-old male twins had nasal lesions on the left eye of twin A and on the right eye of twin B. Both lesions were excised with superior conjunctival autograft. RESULTS: Histopathologic examination showed the lesions to be pterygia. Other pedigrees of familial pterygia have been described. However, to the authors' knowledge, this young age at onset has not been documented with histopathology in twins. CONCLUSIONS: This case report documents the youngest age at onset of pterygia in twins, with histologic confirmation. It suggests a genetic or developmental cause for pterygium formation.

Child↗

Gaze-induced Desçemet's folds secondary to a primary pterygium.

PURPOSE: To report a case of gaze-induced Desçemet's folds secondary to a primary pterygium. METHODS: Interventional case report, chart review, and literature review. RESULTS: Slitlamp examination of a 49-year-old man showed Desçemet's folds in the left eye on extreme right gaze secondary to the restrictive effect of a primary pterygium. The folds correlated with increasing astigmatism documented on corneal topography and restricted ocular motility and diplopia on attempted adduction. CONCLUSIONS: To the authors' knowledge, this is the first reported case of folds induced in Desçemet's membrane secondary to the tethering effect of a primary pterygium.

Astigmatism↗

Post-LASIK corneal flap displacement following penetrating keratoplasty for bullous keratopathy.

OBJECTIVE: To report 3 patients who experienced late flap dislocation after laser in situ keratomileusis (LASIK) in eyes that had undergone prior penetrating keratoplasty (PKP) for bullous keratopathy. METHODS: Retrospective chart review of 2 referral corneal and refractive surgery practices, case reports, and literature review. RESULTS: Three patients (mean age 58.3 years, 2 male, 1 female), all status post-corneal transplant for bullous keratopathy, had residual myopic astigmatism and underwent LASIK for correction of their significant anisometropia. Flap dislocation occurred at a mean of 7 days (range 3 to 14 days) following the LASIK procedure. All patients had peripheral corneal edema in their recipient bed. All 3 patients required an additional surgical procedure for visual rehabilitation. CONCLUSION: Flap displacement may occur following LASIK in patients who have undergone PKP for bullous keratopathy. The endothelial pump function, which is vital to maintaining flap adherence, may be compromised in these patients. We suggest that patients with a history of PKP and endothelial compromise who undergo LASIK wear protective shields for a longer than normal period and be followed closely to reduce the risk of flap slippage.

Adult↗

Hyperthermic treatment of post-LASIK corneal striae.

PURPOSE: To investigate the effect of hyperthermia for the treatment of long-standing corneal flap striae after laser in situ keratomileusis (LASIK). SETTING: TLC Laser Eye Center, Garden City, New York, USA. METHODS: Patients with visually significant flap striae at least 3 weeks post-LASIK were offered hyperthermic treatment. The central 6.0 mm of epithelium was removed from affected corneas, and the flaps were elevated. A striae removal spatula was heated to 65 degrees C in sterile water, and both sides of the flaps were mechanically massaged with the spatula for 5 to 10 minutes until the striae were visually reduced. RESULTS: Thirty-six eyes of 34 patients were treated with hyperthermia to remove corneal striae. All patients had a clinical reduction in striae. The mean pretreatment best corrected visual acuity (BCVA) was 20/44, improving to 20/25 on follow-up (mean follow-up 16.4 months). Patients subjectively noted reduced haze and glare and no loss of BCVA. There were no serious flap complications. CONCLUSION: Hyperthermic treatment is a safe, effective treatment option for corneal striae after LASIK.

Adult↗

Effect of hinge width on corneal sensation and dry eye after laser in situ keratomileusis.

PURPOSE: To investigate the effect of hinge width on corneal sensation and dry-eye syndrome after laser in situ keratomileusis (LASIK). SETTING: TLC Laser Eye Center, Garden City, New York, USA. METHODS: Fifty-four patients at least 18 years of age had bilateral LASIK with a narrow nasal hinge microkeratome flap in 1 eye and a wider nasal hinge microkeratome flap in the other eye. In all eyes, the flaps were 160 microm in thickness with a diameter of 9.5 mm. Masked Cochet-Bonnet esthesiometry was performed in the central cornea preoperatively and at 1 week and 1, 3, and 6 months. Dry eye was evaluated at the same intervals by lissamine green corneal and conjunctival staining, Schirmer test with anesthesia, and tear-film breakup time. RESULTS: Corneal sensation was significantly reduced from preoperative levels through 6 months in the narrow-hinge group and through 3 months in the wider-hinge group (P< or =.002). The mean corneal sensation was greater in corneas with a wider hinge flap than in those with a narrow hinge flap at all postoperative examinations; the difference was significant at 1 and 3 months (P< or =.002). The loss of sensation was greatest at 1 week and improved at all subsequent examinations. Overall, dry-eye signs and symptoms were greatest immediately postoperatively and improved at subsequent intervals. CONCLUSIONS: Corneal sensation and dry-eye signs and symptoms improved at all intervals between 1 week and 6 months. The loss of corneal sensation and presence of dry-eye syndrome were greater in eyes with a narrow hinge flap than in eyes with a wider hinge flap.

Adult↗

Safety and efficacy of ketorolac tromethamine 0.4% ophthalmic solution in post-photorefractive keratectomy patients.

PURPOSE: To evaluate the safety and analgesic efficacy of ketorolac tromethamine 0.4% ophthalmic solution in postoperative photorefractive keratectomy (PRK) patients. SETTING: Fifteen clinical sites in the eastern and southern United States. METHODS: This pooled analysis of 2 multicenter, randomized, double-masked, vehicle-controlled, parallel-group studies comprised 313 patients having unilateral PRK. After surgery, patients were treated with 1 drop of ketorolac tromethamine 0.4% ophthalmic solution (Acular(R) LS) (n = 156) or vehicle (n = 157) 4 times daily for up to 4 days. Pain intensity, pain relief, use of escape medication, and severity of ocular symptoms were assessed. Adverse events, epithelial healing, and visual acuity were recorded. RESULTS: There was significantly less pain intensity experienced by patients in the ketorolac group (P<.001). During the first 12 hours post PRK, 50% fewer patients in the ketorolac group than in the vehicle group had severe to intolerable pain (41.6% [64/154] and 84.5% [131/155], respectively). The median time to no pain was 30 hours in the ketorolac group and 54 hours in the vehicle group (P<.001, survival analysis). Ketorolac patients reported significantly greater pain relief than vehicle patients throughout the study (P<.001). Ketorolac patients used significantly less escape medication than vehicle patients for 48 hours post PRK (P< or =.008). Treatment-related adverse events occurred in 2.6% (4/156) of ketorolac patients and 6.4% (10/157) of vehicle patients. CONCLUSION: Ketorolac 0.4% ophthalmic solution is safe and effective in reducing ocular pain when used 4 times daily for up to 4 days post PRK.

Adolescent↗