Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery

Abstract

Background/aims: To compare the efficacy and safety of intracameral (IC) administration at the beginning of cataract surgery, of Mydrane, a standardised ophthalmic combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%, to a standard topical regimen.

Methods: In this international phase III, prospective, randomised study, the selected eye of 555 patients undergoing phacoemulsification with intraocular lens (IOL) implantation received 200 μL of Mydrane (Mydrane group) just after the first incision or a topical regimen of one drop each of tropicamide 0.5% and phenylephrine 10% repeated three times (reference group). The primary efficacy variable was achievement of capsulorhexis without additional mydriatics. The non-inferiority of Mydrane to the topical regimen was tested. The main outcome measures were pupil size, patient perception of ocular discomfort and safety.

Results: Capsulorhexis without additional mydriatics was performed in 98.9% of patients and 94.7% in the Mydrane and reference groups, respectively. Both groups achieved adequate mydriasis (>7 mm) during capsulorhexis, phacoemulsification and IOL insertion. IOL insertion was classified as 'routine' in a statistically greater number of eyes in the Mydrane group compared with the reference group (p=0.047). Patients in the Mydrane group reported statistically greater comfort than the reference group before IOL insertion (p=0.034). Safety data were similar between groups.

Conclusions: Mydrane is an effective and safe alternative to standard eye drops for initiating and maintaining intraoperative mydriasis and analgesia. Patients who received IC Mydrane were significantly more comfortable before IOL insertion than the reference group. Surgeons found IOL insertion less technically challenging with IC Mydrane.

Trial registration number: NCT02101359; Results.

Keywords: Clinical Trial; Conjunctiva; Cornea; Drugs; Inflammation.

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Figures

Figure 1

Patient selection procedure and distribution of the study population. Only one eye of each patient underwent surgery. Patients scheduled for phacoemulsification cataract surgery were randomised at selection and included in the study on the day of surgery if they fulfilled the protocol inclusion/non-inclusion criteria. They were followed for 28 days postoperatively. †Reasons for patient withdrawal in the Mydrane group: one consent withdrawn; four final visit (D28) not performed or incomplete. Reasons for patient withdrawal in the reference group were one inclusion by error (patient included a second time in the study); one use of a concomitant medication that was prohibited; three final visit (D28) not performed. AE, adverse event; D, day.

Figure 2

Preoperative and perioperative protocols for intracameral administration of a standardised solution of mydriatics and anaesthetic (Mydrane) or standard topical regimen (reference). In the reference group, the patients received one drop each, of tropicamide 0.5% and phenylephrine 10%, repeated three times at 10 min intervals beginning 30 min before surgery. The same regimen of tetracaine 1% (1–2 drops of Tetracaine Faure, Laboratoires Europhta; 1 and 5 min preoperatively) was used in both groups to allow povidone-iodine cleansing of the eyelids before the first incision (start of surgery) and to determine whether there was a difference in comfort between groups. Patients in the Mydrane group were injected with 200 μL of Mydrane in the anterior chamber just after the first corneal incision. Subsequently, a waiting time of 1.5 min (with the surgical microscope light switched off) was required by the protocol after injection of Mydrane and before delivery of viscoelastic, denoted by (a) in the figure. If mydriasis was considered inadequate after 1.5 min, a supplementary injection of 100 μL was permitted at the surgeon's discretion. Pheny, phenylephrine 10%; PKE, phacoemulsification; Tetra, tetracaine 1%; Tropi, tropicamide 0.5%.

Figure 3

Between-group comparison of the pupil size (in classes) during cataract surgery in the modified intent-to-treat set of patients. Pupil diameters were determined from photographs of the video recordings and measured by independent and masked observers at T3 (just before capsulorhexis), T4 (just before intraocular lens (IOL) implantation) and T5 (just before cefuroxime injection, end of surgery). The green arrow indicates pupil diameter to the right is ≥6 mm. Mydrane, Mydrane group; Ref, reference group.

Figure 4

Percentage of the modified intent-to-treat-anaesthesia set of patients with ‘no sensation of pain in the eye or the orbit’ or ‘no sensation of pressure in the eye or the orbit’ at each time point during surgery (T1: before the first incision; T2: before viscoelastic injection; T3: before capsulorhexis; T4: before intraocular lens implantation; T5: before cefuroxime injection). Ocular discomfort was evaluated by the patients using a questionnaire. Mydrane, Mydrane group; %Patient, per cent of patients; Reference, reference group.

Figure 5

Preoperative and surgical times (minutes) in the modified intent-to-treat set of patients. The times analysed were the time necessary for obtaining mydriasis (defined as the delay between the first instillation (eg, first injection of Mydrane for the Mydrane group or first instillation of tropicamide and phenylephrine for the reference group) and T3); time necessary to perform the main technical part of the surgical procedure, that is, from capsulorhexis to cefuroxime injection (defined as the delay between T3 and T5); total surgical time (T1–T5) and time spent by the patient in the operating theatre (from instillation of the first eye drop to cefuroxime injection). T1, before the first incision; T3, before capsulorhexis; T5, before cefuroxime injection. Analysis of covariance was used for between-group comparisons for the times T1–T5 and T3–T5 (p