Nylon Verus Polyglactin Corneal Suture in Pediatric Cataract Surgery
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|ClinicalTrials.gov Identifier: NCT03812640|
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : January 25, 2019
Pediatric cataract surgery requires the suturing of the corneal incision in order to maintain the integrity of the eyeball and to help avoid the trauma often caused by scratching in the postoperative period of pediatric surgeries. Traditionally, this suturing is performed using 10-0 nylon material. Because this material is non-absorbable, it must be removed under sedation in cases of complications such as suture loosening, late suture lysis, accumulation of secretion on the suture, corneal neovascularization, and corneal ulceration. The objetive of this study is to compare the rate of postoperative complications and the need for suture removal after pediatric cataract surgery in cases in which nylon (non-absorbable) sutures are used versus cases in which polyglactin (absorbable) sutures are used.
This is a controlled, randomized, prospective, single-center study performed on patients undergoing pediatric cataract surgery at the Clinical Hospital of the University of Campinas (UNICAMP). The volunteers for whom cataract extraction surgery has been indicated and who have signed the ICF (or whose ICF has been signed by a parent or guardian) will undergo cataract surgery and the cornea will be sutured using a polyglactin 910 suture (Vicryl® 10-0). In the control group (Group B), the cornea will be sutured using nylon 10-0 sutures (the current routine procedure). All patients will be monitored for six months and will receive complete ophthalmological evaluations in order to determine whether they experience any suture-related complications and whether sutures must be removed under sedation. A lower incidence of complications and a less frequent need for suture removal under sedation are expected in the group receiving Vicryl® sutures.
|Condition or disease||Intervention/treatment||Phase|
|Endophthalmitis Cataracts Infantile Suture, Complication||Device: Vicryl suture Device: Nylon suture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison Between Nylon and Polyglactin Corneal Suture in Pediatric Cataract Surgery: a Randomized Controlled Clinical Trial|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||October 1, 2019|
Device: Vicryl suture
Corneal suture with Vicryl suture
Active Comparator: Nylon
Device: Nylon suture
Corneal suture with Nylon suture
- frequency of complications associated with sutures in each group [ Time Frame: 180 days ]frequency of complications associated with sutures in each group
- need for suture removal under sedation in each group. [ Time Frame: 180 days ]need for suture removal under sedation in each group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812640
|Contact: Mathias Melega, MD||+55 19 firstname.lastname@example.org|
|Mathias Violante Mélega||Recruiting|
|Campinas, São Paulo, Brazil, 13025-050|
|Contact: Mathias V Mélega 19997513150 email@example.com|