Double-masked, placebo-controlled safety and efficacy trial of diquafosol tetrasodium (INS365) ophthalmic solution for the treatment of dry eye.

PURPOSE: To investigate the safety and efficacy of diquafosol tetrasodium, a P2Y2 receptor agonist that stimulates fluid and mucin secretion on the ocular surface, as a novel topical treatment of dry eye disease. METHODS: Subjects with dry eye (n=527) were evaluated in a randomized, double-masked, parallel-group trial comparing 24 weeks of treatment with 2 concentrations of diquafosol (1% and 2%) versus placebo instilled 4 times daily. Corneal staining, conjunctival staining, Schirmer tests, and subjective symptoms of dry eye were evaluated. Use of artificial tears was permitted as necessary. RESULTS: Subjects treated with 2% diquafosol had significantly lower corneal staining scores compared with placebo at the 6-week, primary efficacy time point (P<0.001), and superiority continued throughout the 24-week study. Reductions in corneal staining were observed as early as after 2 weeks of treatment, were maintained throughout the 24-week study, and were observed to worsen slightly (toward baseline) when diquafosol treatment was discontinued (week 25). Results for conjunctival staining were consistent with those observed for corneal staining. Schirmer scores at week 6 were significantly higher with diquafosol treatment than with placebo (P

Penetrating keratoplasty with vitreoretinal surgery using the Eckardt temporary keratoprosthesis: modified technique allowing use of larger corneal grafts.

UNLABELLED: We report our experience with the Eckardt temporary keratoprosthesis including a technique modification allowing use of larger corneal grafts. We combined penetrating keratoplasty with vitreoretinal surgery using the Eckardt keratoprosthesis in 24 eyes of 24 patients in two patient groups: trauma (n = 11) and nontrauma (n = 13). Our technique modification involved centering a larger partial trephination for the donor cornea around the smaller trephination used for the keratoprosthesis. After the keratoprosthesis was removed, we excised host cornea graft. With the exception of visual acuity (VA), the outcomes were similar for both trauma and nontrauma groups, and combined results were as follows. Corneal grafts remained clear in 71% of patients at a mean follow-up period of 16 +/- 3 (SE) months. For the trauma and nontrauma groups, VA improved in 82 and 23%, and decreased in 18% and 38.5%, respectively. Postoperative loss of VA was due primarily to retinal scarring (47%) and phthisis bulbi (37%). Only one case of graft rejection occurred. Postoperatively, the larger corneal grafts (8.0 and 8.5 mm) were less steep, and residual astigmatism was more easily managed than with the "recommended" (7.2 mm) size. CONCLUSIONS: Larger corneal grafts allow less astigmatism and a more normal corneal curvature. Theoretical advantages also include faster rehabilitation of vision, better predictability for intraocular lens implant power calculations, and transplantation of more endothelial cells. The Eckardt will continue to be a useful tool and our technique modification allowing use of larger corneal grafts should enhance its utility.

Surgical treatment of calcific band keratopathy.

A surgical technique utilizing ethylenediaminetetraacetic acid (EDTA) and a Fisch drill with a diamond burr for removal of calcific band keratopathy is presented. Use of a diamond burr is an effective and simple method of removing resistant calcium deposits from the cornea without causing significant scarring.

A randomized trial of topical corticosteroids in epithelial healing after keratoplasty.

A prospective randomized trial evaluating the effect of topical 1% prednisolone acetate on epithelial defects after keratoplasty in 39 patients (18 in the untreated group and 21 in the treated group) failed to reveal any significant differences in healing between the two groups (p less than 0.16 to p less than 0.54 on post-operative days 1-5). The mean time needed for complete healing was 1.94 days in the untreated group and 2.81 days in the steroid treated group (p less than 0.09). Patients given subconjunctival methylprednisolone sodium succinate had larger initial defects (mean 33.5 mm2) than those not given subconjunctival steroids (mean 16.1 mm2), but the time for complete epithelial healing did not differ significantly (2.75 days vs. 1.91 days; p less than 0.14). As clinically used post-keratoplasty topical steroids do not appear to significantly delay epithelial healing in most patients.