Evaluation of a new preoperative ophthalmic solution.

BACKGROUND: Maximum mydriasis and corneal clarity during intraocular surgery are important to ensure operational safety. However, repeated instillation of mydriatic and anti-inflammatory ophthalmic solutions during surgery may affect compliance and may damage the corneal epithelium. We developed an ophthalmic solution containing tropicamide, phenylephrine hydrochloride and diclofenac sodium, and compared the properties and effect on corneal epithelial barrier function and on mydriasis of the solution and of its individual components. METHODS: We developed the ophthalmic solution by mixing 10 mL of 0.5% tropicamide/0.5% phenylephrine, 10 mL of 5% phenylephrine and 10 mL of 0.1% diclofenac (TPD). We determined the stability of the chemicals in solution using high-performance liquid chromatography immediately, 1 week and 1 month after mixing. Corneal epithelial barrier function was assessed before and after instillation of the solutions in 26 eyes of 17 patients (5 with proliferative diabetic retinopathy or diabetic maculopathy, 8 with cataract and 4 with no eye disease). The fluorescent intensity was measured 10 times at the central cornea 30 minutes after instillation of 3 mL of 0.5% fluorescein solution and the average value calculated. Finally, the pupil diameter of 50 eyes of 38 patients undergoing cataract surgery was measured before and immediately after the operation. RESULTS: No remarkable changes in the pH or pharmacologic activity of the TPD solution were observed at any time after mixing. In the patients with diabetic retinopathy or cataract, the increase in mean fluorescent intensity was significantly greater with the individual solutions than with the TPD solution (p < 0.01); there was no significant difference in mean fluorescent intensity in the subjects with no eye disease. No statistically significant difference in pupil diameter was observed between the eyes that received the TPD solution and those that received the individual solutions. INTERPRETATION: TPD ophthalmic solution is simple to prepare and use. The TPD solution had a similar effect on mydriasis as the three individual solutions but was less destructive to the corneal epithelium.

[TPD ophthalmic solution (mixture of tropicamide, phenylephrine hydrochloride, and diclofenac sodium) for cataract surgery].

PURPOSE: We made a TPD ophthalmic solution by combining tropicamide solution(Mydrin-P: T), phenylephrine hydrochloride(Neosynesin Kowa: P) and diclofenac sodium(Diclod: D), and evaluated its efficiency in mydriasis during cataract surgery compared to T, P, and D. SUBJECTS AND METHODS: Twenty-five eyes(19 patients) were given either TPD solution(10 eyes) or T, P, and D solution(15 eyes), and the treatment was given six times before surgery. Pupil diameters were measured before and after surgery. RESULT: The operation time was 10.0 +/- 5.2(mean +/- standard deviation) minutes in the TPD group, and 9.0 +/- 3.6 minutes in the T, P and D group. The preoperative and postoperative one pupil diameter was 8.65 +/- 0.34 mm and 8.20 +/- 0.35 mm in the TPD group and 8.80 +/- 0.49 mm and 8.37 +/- 0.61 mm in the T, P, and D group, respectively. The rate of miosis was 5.1 +/- 4.2% in the TPD group and 4.8 +/- 5.1% in the T, P, and D group, respectively. There was no statistically significant difference between the two groups. CONCLUSION: TPD ophthalmic solution maintains the mydriasis as potent by as T, P and D solution.

[Availability of TPD ophthalmic solution (mixture of Mydrin-P solution, Neosynesin Kowa solution, and Diclod solution) in regard to the corneal barrier function--clinical evaluation for vitrectomy in patients with diabetic retinopathy].

PURPOSE: We made TPD ophthalmic solution by combining Tropicamide solution(Mydrin-P: T), Phenylephrine Hydrochloride(Neosynesin Kowa solution: P) and Diclofenac Sodium(Diclod solution: D), and evaluated its efficiency in terms of corneal epithelial damage in patients with diabetic retinopathy. SUBJECTS AND METHODS: Five patients(10 eyes) who were to undergo vitrectomy were enrolled in this study. They each received T, P, and D 6 times and TPD solution in the same way. Before and after the instillation, superficial punctate keratopathy (SPK) was evaluated and corneal epithelial permeability was determined by anterior fluorophotometry. RESULTS: After the instillation of T, P, and D, corneal damage increased in all eyes. After the instillation of TPD, three eyes showed only one grade change up in AD(A: area, D: density) classification of SPK. The fluorescein uptake change between pre- and post-instillation was 457.5 +/- 468.8 (mean +/- standard deviation) ng/ml with T, P, and D and 100.5 +/- 235.6 ng/ml with TPD(p < 0.01). CONCLUSION: TPD solution decreases both corneal epithelium damage and barrier function change of corneal epithelium.