Evaluation of efficacy and safety of new high-density dyes for chromovitrectomy.

The purpose of this study is to evaluate the safety and efficacy of two novel heavy dyes for macular surgery: DoubledyneTM and TwinTM. One eye from each of 144 patients undergoing surgery for macular hole or macular pucker was included in the study. The eyes were randomly divided into two groups according to the dye used during surgery. Best correct visual acuity (BCVA), intraocular pressure (IOP) and retinal morphology assessed by ocular coherence tomography (OCT) were evaluated before and 1, 3, 6 and 12 months after surgery. Only one surgeon performed each operation and provided a score ranging from 1 (poor) to 10 (excellent) for quality of staining and comfort in surgery. Statistical analysis was carried out with SPSS to compare parameters before and after surgery and between the two groups. No statistical differences were recorded in quality of staining (p = 0.11), in surgery comfort (p = 0.17) and total time of surgery (p = 0.44) between the two groups. BCVA statistically improved and central macular thickness (CMT) statistically decreased after surgery in both groups (p < 0.05). No toxic dye-related complications or long-term ones affecting the retina were observed in either group. According to this data, although confirmation in further studies with larger populations and longer follow up is required, DoubledyneTM and TwinTM proved to be safe and effective dyes for macular surgery.

RCT Entities:   Population Interventions Outcomes