Intracameral Anaesthetic Mydriatic Versus Topical Mydriasis in Pediatric Cataract Surgery: A Randomized Control Study

To compare pupil dynamics after using premixed intracameral anesthetic mydriatic combination (ICAM) of phenylephrine (0.31%), tropicamide (0.02%), and lidocaine (1%) versus topical mydriatic (TM) drops consisting of tropicamide 0.8%, phenylephrine 5%, and cyclopentolate 0.5% in pediatric cataract surgery.

Randomized, masked, fellow eye-controlled trial.

Tertiary eye care facility.

Children ≤12 years of age with bilateral cataracts planned for surgery. One eye was randomized to receive ICAM and the other eye (control) TM drops.

Commercially available ICAM that was injected at the beginning of surgery or TM 3 times at an interval of 30 minutes, 1 hour before the scheduled time of surgery. The other treatment was administered for the second eye cataract surgery.

Pupil dynamics at various points of surgery were studied by a masked observer.

Sixty-three patients (126 eyes) were randomized to receive ICAM in 1 eye (group 1) or TM drops (group 2). The mean age of the children in the study was 15.7 ± 24.3 months (range 3 months to 5 years). Adequate mydriasis with a single injection was achieved in 93.5% of patients in group 1 and 88.8% of patients in group 2 without additional pharmacotherapy or intervention. The mean pupillary diameter increased from 1.78 mm to 5.1 mm after injection of 1 unit of ICAM and from 1.75 mm to 6.06 mm with TM drops (P < .0001). The maximum pupillary dilation achieved was 6.06 ± 1.17 mm in group 1 and 6.75 ± 1.07 mm in group 2 (P = .004). The average change in pupillary size from injection of drug until the end of surgery was positive in group 1 (0.75 ± 0.98 mm) and negative in group 2 (-0.3348 ± 2.57 mm), ie, there was a relative miosis in group 2 toward the end of surgery (P = .001).

Topical drugs achieved a larger maximum pupil size compared with ICAM. However, ICAM provided adequate and stable mydriasis without the need for augmentation compared with topical drops in children undergoing cataract surgery.