A Placebo-controlled, Double-masked Evaluation of Mitomycin C in Combined Glaucoma and Cataract Procedures

• Published in: Ophthalmology (Rochester, Minn.) Vol. 103; no. 11; pp. 1934 - 1942
• Main Authors: Cohen, John S., Greff, Linda J., Novack, Gary D., Wind, Brian E.
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.11.1996; Elsevier
• Subjects: Aged; Aged, 80 and over; Biological and medical sciences; Cell Count; Chemotherapy, Adjuvant; Double-Blind Method; Endothelium, Corneal - cytology; Eye; Female; Follow-Up Studies; Glaucoma - drug therapy; Glaucoma - surgery; Humans; Intraocular Pressure; Lenses, Intraocular; Male; Medical sciences; Middle Aged; Mitomycin - therapeutic use; Nucleic Acid Synthesis Inhibitors - therapeutic use; Phacoemulsification; Pharmacology. Drug treatments; Postoperative Complications; Trabeculectomy; Visual Acuity; Human; Trabeculectomy; Cataract; Mitomycin; Adjuvant treatment; Implantation; Phacoemulsification; Eye disease; Chemotherapy; Lens disease; Antimetabolic; Glaucoma (eye); Surgery; Double blind study; Intraocular lens; Anterior segment disease
• ISSN: 0161-6420; 1549-4713
• DOI: 10.1016/S0161-6420(96)30405-3

Purpose: This study was performed to determine if adjunctive use of mitomycin C (MMC) would increase the success of combined phacoemulsification, intraocular lens implantation, and trabeculectomy surgery with releasable sutures. Methods: Seventy-two eyes with cataract and glaucoma, requiring surgery for decreased vision, uncontrolled intraocular pressure, or to obtain a better view of the optic nerve, were randomized to receive a 2.5-minute subconjunctival exposure to either MMC (0.5 mg/ml) or placebo balanced salt solution. Postoperative evaluations at 3, 6, and 12 months were performed by a masked observer who recorded visual acuity, intraocular pressure, glaucoma medications, presence of filtering blebs, and complications. Endothelial cell counts were measured before and 3 months after surgery. Results: The MMC group had significantly greater reduction in mean intraocular pressure through the first 12 months of follow-up (7.05–7.65 mmHg versus 2.62–3.84 mmHg; P = 0.001–0.028). In addition, through the first 6 months of follow-up, the MMC group required significantly fewer medications (0.4–0.5 versus 1.1–1.2; P = 0.002–0.004). Requirements for additional glaucoma surgery were less in the MMC group (4/36) than in the placebo group (7/35) (P = 0.301). Filtering blebs were significantly larger at 6 and 12 months (P = 0.002 and P = 0.001, respectively), and wound leaks were more common (P = 0.101) in the MMC group. The mean decrease in endothelial cell count at month 3 was slightly, although not significantly, greater in the MMC treatment group (206.9 versus 91.3 cells/mm2* P = 0.377). Conclusion: The increased success of the glaucoma procedure in the MMC group, together with relatively minor toxicity, suggests its use is beneficial in combined glaucoma-cataract surgery.