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

Abstract

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.

Risk factors of post-operative optic nerve injury after vitrectomy: a systematic review

“…This study also reported no toxic dye-related complications were observed in either group. 14 Similar result was shown in Toba et al (2014), this study compared the changes of RNFL thickness in macular holes after vitrectomy with indocyanine green-(ICG-), brilliant blue G-(BBG-), and triamcinolone acetonide (TA-) assisted ILM peeling. This study reported no significant difference regarding RNFL thickness between those groups for at least 12 months postoperatively.…”

“…and TwinTM (Trypan blue 0.18% and Blulife 0.03%) group. 14 Rohrig et al (2019) also reported no significant difference between the use of MBB and AV 17-M in terms of inner segment/outer segment defect. 16 Our study has a few limitations.…”

“…Bias arising from the randomization process was seen in all RCTs, due to none reported a concealment of allocation sequence. Nikolaenko et al 9 and Picirillo et al 14 also had possible bias due to missing outcome data. The risk of bias in RCT is shown in Figure 2 and Figure 3.…”

“…This technique involves the use of dyes, which selectively bind to the ILM and make it easier to identify and remove during surgery. [14][15][16] Indocyanine green (ICG) was the initial dye utilized for macular hole (MH) surgery. 43 However, it was subsequently discovered that the concentrations of ICG utilized during vitrectomy were toxic to the retina.…”

Idiopathic Epiretinal Membrane Surgery in Patients Aged Over 80 Years: Efficacy and Safety

“… 2 ERM often causes metamorphopsia and visual impairment in the elderly population. For most patients with idiopathic ERM, the standard clinical therapy is pars plana vitrectomy (PPV) with ERM peeling, combined with internal limiting membrane (ILM) peeling, 3 , 4 with about 70% of patients improving visual acuity two lines or more. 5 , 6 A study by Jackson et al 1 has shown that 9.8% of the patients undergoing ERM surgeries have surgical complications, including lens touch, iatrogenic retinal trauma, posterior capsular rupture, and corneal edema.…”