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Nylon Verus Polyglactin Corneal Suture in Pediatric Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03812640
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Mathias Violante Mélega, University of Campinas, Brazil

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Vicryl
Vicryl suture
Device: Vicryl suture
Corneal suture with Vicryl suture

Active Comparator: Nylon
Nylon suture
Device: Nylon suture
Corneal suture with Nylon suture




Primary Outcome Measures :
  1. frequency of complications associated with sutures in each group [ Time Frame: 180 days ]
    frequency of complications associated with sutures in each group


Secondary Outcome Measures :
  1. need for suture removal under sedation in each group. [ Time Frame: 180 days ]
    need for suture removal under sedation in each group.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients up to 14 years of age who are clinically qualified to undergo pediatric cataract surgery

Exclusion Criteria:

  • Traumatic cataract with ocular perforation
  • Cataract surgery associated with other procedures, such as glaucoma filtering surgery, vitreoretinal surgery, and cornea surgery
  • Signs of ocular or periocular infection
  • Advanced glaucoma

Information from the National Library of Medicine

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


Contacts
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Contact: Mathias Melega, MD +55 19 997513150 mvmelega@hotmail.com

Locations
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Brazil
Mathias Violante Mélega Recruiting
Campinas, São Paulo, Brazil, 13025-050
Contact: Mathias V Mélega    19997513150    mvmelega@hotmail.com   
Sponsors and Collaborators
University of Campinas, Brazil

Publications:
WHO | Priority eye diseases. WHO [Internet]. 2014 [cited 2017 Dec 29]; Available from: http://www.who.int/blindness/causes/priority/en/index3.html
Wilson BME. Pediatric Cataracts : Overview Classification ( Categorization ). 2016;
Heaven CJ, Boase DL. Suppurative keratitis with endophthalmitis due to biodegraded full thickness monofilament nylon corneal sutures. Eur J Implant Refract Surg [Internet]. 1993;5(3):164-8. Available from: http://dx.doi.org/10.1016/S0955-3681(13)80436-4
Danjoux JP, Reck AC, to C. CORNEAL SUTURES: IS ROUTINE REMOVAL REALLY NECESSARY? [cited 2017 Dec 28]; Available from: https://www.nature.com/articles/eye199470.pdf

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Responsible Party: Mathias Violante Mélega, MD, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT03812640    
Other Study ID Numbers: Vicryl Unicamp
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mathias Violante Mélega, University of Campinas, Brazil:
pediatric
cataract
suture
poliglactin
nylon
Additional relevant MeSH terms:
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Endophthalmitis
Cataract
Lens Diseases
Eye Diseases
Eye Infections
Infection