Comparison Between Nylon and Polyglactin Corneal Suture in Pediatric Cataract Surgery: a Randomized Controlled Clinical Trial

Patients who are diagnosed with cataracts and for whom surgery is indicated shall be evaluated (as much as possible based on their ability to cooperate with the assessment) in terms of their visual acuity and refractive error via biomicroscopy, automated keratometry (Auto Kerato Refractometer KR 8000® Alcon), Goldmann applanation tonometry, fundoscopy, and biometric assessment (Ocuscan RxP® Alcon or Lenstar LS900® Haag-Streit International).

Patients who choose to sign (or whose guardians choose to sign) the informed consent form after being informed of all of the aspects of the surgery and this trial shall be randomly divided into one of two groups that shall be approximately equal in size and stratified by age.

• Up to 6 months of age
• From 6 to 12 months of age
• From 1 to 3 years of age
• From 3 to 6 years of age
• Older than 6 years Patients in Group A will have their surgical incisions sutured with polyglactin 10-0 material (Vicryl®, composed of polyglactin 910, 10-0 diameter, absorbable, a 0.62 cm, 3/8 circle needle) at the end of cataract surgery followed by the use of 0.5% moxifloxacin and 0.1% dexamethasone eye drops before the bandage is applied. Patients in Group B will have their surgical incisions sutured with nylon 10-0 material (Vicryl®, composed of nylon monofilament, 10-0 diameter, absorbable, a 0.55 cm, 1/2 circle needle) at the end of cataract surgery followed by the use of 0.5% moxifloxacin and 0.1% dexamethasone eye drops before the bandage is applied.

Cataract surgery will be performed using the standardized protocol in the Ophthalmology department of UNICAMP by fourth-year ophthalmology residents with experience in pediatric cataract surgery. Preoperative pupil dilation shall be performed through the use of 2.5% phenylephrine and 1% tropicamide 3 times in five-minute increments. General anesthesia shall be performed. Skin sterilization shall be performed using an aqueous solution of 10% povidone-iodine. After the sterile surgical field is established and the eyelashes are isolated, 4 eye drops containing 5% povidone-iodine shall be administered in the conjunctival sac with subsequent irrigation using a 10% balanced salt solution. In cases of allergy to povidone-iodine, an aqueous solution of 0.05% chlorhexidine shall be used. The main incision (either a clear corneal incision or a scleral tunnel) will be 2.2 mm to 3.0 mm, and aspiration will be applied using the Infiniti® or Laureate® phacoemulsifier (Alcon) with a foldable AcrySof® intraocular lens (Alcon) and a posterior capsulotomy with an automated vitrectomy only in cases in which it is indicated.

Neither patients nor surgeons will be masked to the study treatment. The postoperative consultations will be held on the first, seventh, thirtieth, ninetieth, one hundred and twentieth, and one hundred and eightieth postoperative days and will include visual acuity assessments, refractive error assessments, keratometry , biomicroscopy, applanation tonometry, and fundoscopy, depending on the patient's age and ability to cooperate. If a necessary exam is not possible in a clinical setting, it will be performed under sedation in the surgical center.