Efficacy of rhBMP-2/Hydroxyapatite on Sinus Floor Augmentation: A Multicenter, Randomized Controlled Clinical Trial.

The aim of this randomized single-blinded active-controlled clinical study was to evaluate the early efficacy of low-dose Escherichia coli-derived recombinant human bone morphogenetic protein 2 (rhBMP-2) soaked with hydroxyapatite granules (BMP-2/H) as compared with an inorganic bovine bone xenograft (ABX) in maxillary sinus floor augmentation. In a total of 127 subjects who were enrolled at 6 centers, maxillary sinus floors were augmented with 1 mg/mL of rhBMP-2 (0.5 to 2.0 mg per sinus) and BMP-2/H (0.5 to 2.0 g; n = 65) or with ABX alone (0.5 to 2.0 g; n = 62). Core biopsies were obtained 3 mo after the augmentation surgery and were analyzed histomorphometrically. The mean new bone formation with BMP-2/H and ABX augmentation was 16.10% ± 10.52% and 8.25% ± 9.47%, respectively. The BMP-2/H group was noninferior to the ABX group; the lower limit of the 1-sided 97.5% confidence interval for the difference between the 2 groups was calculated as 4.33%, which was greater than the prespecified noninferiority margin of -3.75%. An additional test with the Wilcoxon rank-sum test with a 2-sided 5% significance level showed that bone formation between the 2 groups was significantly different (P < 0.0001). The soft tissue and residual graft areas showed no significant differences between the groups. With regard to safety, no significant difference between the 2 groups was observed; there was no significant increase in the amount of rhBMP-2 antibody in the serum after BMP-2/H grafting. Our study suggested that low-dose Escherichia coli-derived rhBMP-2 with hydroxyapatite was effective in early stages for enhanced bone formation after maxillary sinus floor augmentation without harmful adverse events (Clinicaltrials.gov NCT01634308).

Short-term effect of mitomycin-C augmented trabeculectomy on axial length and corneal astigmatism.

PURPOSE: To evaluate the short-term effect of trabeculectomy with adjunctive mitomycin-C (MMC) on corneal astigmatism and axial length. SETTING: Asan Medical Center, University of Ulsan, Department of Ophthalmology, Seoul, Korea. METHODS: Eighteen consecutive eyes of 16 patients having trabeculectomy with adjunctive MMC were prospectively analyzed. Intraocular pressure (IOP) and axial length were evaluated preoperatively and 1, 3, 6, and 12 months postoperatively. Postoperative changes in corneal astigmatism were evaluated using vector analysis. RESULTS: The overall mean induced astigmatism showed with-the-rule change up to 3 months postoperatively followed by an against-the-rule shift. The mean axial length was significantly less postoperatively and changed throughout the 12 month follow-up. There was a positive correlation between postoperative axial length and IOP. Eyes with higher preoperative IOP had a greater decrease in axial length after trabeculectomy with MMC. CONCLUSION: The induced corneal astigmatism after trabeculectomy with MMC was long lasting, although less than that in previous studies. The change in axial length after surgery was significant, especially in eyes with a high preoperative IOP. The decrease in axial length persisted throughout the follow-up.

Increases in intraocular pressure during hemodialysis in eyes during early postvitrectomy period.

BACKGROUND AND OBJECTIVES: To identify risk factors for intraocular pressure (IOP) increases during hemodialysis (HD) in the early postoperative period following pars plana vitrectomy (PPV). PATIENTS AND METHODS: Comparisons of 36 vitrectomized eyes of 22 diabetics undergoing maintenance HD with those of 138 eyes of 69 nonoperated patients. Serial IOPs were measured before PPV, after PPV/before dialysis, and during dialysis. Serum osmolarity and blood pressure were also recorded. RESULTS: In 20 of 36 operated eyes (55.6%) and 18 of 138 nonoperated eyes (13.0%) IOP was increased (> or =4 mm Hg) during HD. In the operated group, marked increases (> or =7 mm Hg) were noted in 9 eyes and ocular pain in 5 eyes. Eyes with pre-existing outflow obstruction and/or acute postoperative outflow compromise carried high risks. No correlation with changes in serum osmolarity or blood pressure was found. CONCLUSION: Monitoring of IOP during HD seems warranted when diabetics with pre-existing outflow obstruction and/or postoperative outflow compromise, undergo HD following PPV.

Clinical results of Ahmed glaucoma valve implantation in refractory glaucoma with adjunctive mitomycin C.

OBJECTIVE: To study the surgical outcome and complications of Ahmed glaucoma valve (AGV) implantation with mitomycin C (MMC) in refractory glaucoma. PATIENTS AND METHODS: The authors retrospectively reviewed the records of 40 eyes in 37 consecutive patients who underwent combined AGV with MMC (0.4 mg/mL; 5 minutes). All patients had a minimum of 6 months of follow-up. Outcome measures were best corrected visual acuity, intraocular pressure (IOP), the number of medications, success rates, and the incidence of complications. RESULTS: The Kaplan-Meier life table analysis revealed that the probabilities of surgical success based on our success criteria at 1 year and 2 years postoperatively were 80% and 77%, respectively. Postoperative IOP was significantly lower at all follow-up intervals. At the final visit fewer glaucoma medications were used (2.5 vs 0.7, preoperative vs postoperative). The most frequent complication was hypotony (17%). CONCLUSION: In this retrospective case series with relatively short follow-ups, AGV implantation with mitomycin C in refractory glaucoma appears to be effective without increased complication rates.

The immediate effect of bilateral superior obliuqe tenotomy on primary position horizontal binocular alignment.

PURPOSE: To evaluate the effect on primary position horizontal binocular alignment of superior oblique tenotomy for A-pattern exotropia with bilateral superior oblique overaction using new surgical and anesthesia techniques. SUBJECTS AND METHODS: We performed intraoperatively adjustable horizontal strabismus surgery under topical anesthesia in 6 cases of A-pattern exotropia. After adjusting the horizontal deviation nearly to orthotropia in primary position, we measured the angle of horizontal deviation in up-, primary, and downgaze positions. This was followed by bilateral superior oblique tenotomy and remeasurement of the horizontal deviation in the same 3 positions. Postoperatively we remeasured the deviation at one day, one month and three months. RESULTS: There was no immediate change in the horizontal deviation in primary position in 2 of the 6 patients, and 3-8 delta of immediate esotropic shift in 4 of the 6 patients (average 3.3 delta) after bilateral superior oblique tenotomy. At 3 months postop' the small esotropia noted at the immediate postop' measurement became orthotropic. There was a tendency of increased exotropic shift or becoming exotropic in those patients with slight exotropia or orthotropia at the immediate postop' measurement. But these shifts were minimal. CONCLUSION: When combined surgery of superior oblique and horizontal muscle is planned for A-pattern exotropia, the effect of bilateral superior oblique tenotomy on the primary position horizontal binocular alignment can be disregarded.

Penetrating keratoplasty for pseudophakic bullous keratopathy associated with semiflexible, closed-loop anterior chamber intraocular lenses.

We performed penetrating keratoplasty on 32 eyes that developed pseudophakic bullous keratopathy associated with closed-loop anterior chamber intraocular lenses. All lenses were exchanged at the time of keratoplasty. Seventeen patients received anterior chamber intraocular lenses and 15 patients had a posterior chamber lens sutured to the iris or sclera. Postoperatively, 13 of 32 eyes (41%) achieved a visual acuity of 20/100 or better, and 27 of 32 eyes (84%) had a clear graft. A high incidence of cystoid macular edema (eight cases), and graft rejection (seven cases) resulted in marked visual loss.