Nylon Verus Polyglactin Corneal Suture in Pediatric Cataract Surgery

NCT03812640 | Unknown DMC

• 1 other identifier: Vicryl Unicamp
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Endophthalmitis; Cataracts Infantile; Suture, Complication

Keywords

pediatric; cataract; suture; poliglactin; nylon

Outcome Measures

Primary Outcomes (1)

• frequency of complications associated with sutures in each group

  frequency of complications associated with sutures in each group

  180 days

Secondary Outcomes (1)

• need for suture removal under sedation in each group.

  180 days

Study Arms (2)

Vicryl

EXPERIMENTAL

Vicryl suture

Device: Vicryl suture

Nylon

ACTIVE COMPARATOR

Nylon suture

Device: Nylon suture

Interventions

Vicryl suture DEVICE

Corneal suture with Vicryl suture

Vicryl

Nylon suture DEVICE

Corneal suture with Nylon suture

Nylon

Eligibility Criteria

• Age: 30 Days - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Mathias Violante Mélega

Campinas, São Paulo, 13025-050, Brazil

RECRUITING

Related Publications (14)

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  PMID: 9278811 BACKGROUND

• Gilbert CE, Wood M, Waddel K, Foster A. Causes of childhood blindness in east Africa: results in 491 pupils attending 17 schools for the blind in Malawi, Kenya and Uganda. Ophthalmic Epidemiol. 1995 Jun;2(2):77-84. doi: 10.3109/09286589509057086.

  PMID: 7585238 BACKGROUND

• Haargaard B, Wohlfahrt J, Fledelius HC, Rosenberg T, Melbye M. Incidence and cumulative risk of childhood cataract in a cohort of 2.6 million Danish children. Invest Ophthalmol Vis Sci. 2004 May;45(5):1316-20. doi: 10.1167/iovs.03-0635.

  PMID: 15111583 BACKGROUND

• WHO | Priority eye diseases. WHO [Internet]. 2014 [cited 2017 Dec 29]; Available from: http://www.who.int/blindness/causes/priority/en/index3.html

  BACKGROUND

• Wilson BME. Pediatric Cataracts : Overview Classification ( Categorization ). 2016;

  BACKGROUND

• 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

  BACKGROUND

• Lee BJ, Smith SD, Jeng BH. Suture-related corneal infections after clear corneal cataract surgery. J Cataract Refract Surg. 2009 May;35(5):939-42. doi: 10.1016/j.jcrs.2008.10.061.

  PMID: 19393897 BACKGROUND

• Culbert RB, Devenyi RG. Bacterial endophthalmitis after suture removal. J Cataract Refract Surg. 1999 May;25(5):725-7. doi: 10.1016/s0886-3350(99)00020-6.

  PMID: 10330655 BACKGROUND

• Khurshid GS, Fahy GT. Endophthalmitis secondary to corneal sutures: series of delayed-onset keratitis requiring intravitreal antibiotics. J Cataract Refract Surg. 2003 Jul;29(7):1370-2. doi: 10.1016/s0886-3350(03)00404-8.

  PMID: 12900247 BACKGROUND

• Acheson JF, Lyons CJ. Ocular morbidity due to monofilament nylon corneal sutures. Eye (Lond). 1991;5 ( Pt 1):106-12. doi: 10.1038/eye.1991.20. No abstract available.

  PMID: 2060657 BACKGROUND

• Danjoux JP, Reck AC. Corneal sutures: is routine removal really necessary? Eye (Lond). 1994;8 ( Pt 3):339-42. doi: 10.1038/eye.1994.70.

  PMID: 7958043 BACKGROUND

• Bainbridge JW, Teimory M, Kirwan JF, Rostron CK. A prospective controlled study of a 10/0 absorbable polyglactin suture for corneal incision phacoemulsification. Eye (Lond). 1998;12 ( Pt 3a):399-402. doi: 10.1038/eye.1998.94.

  PMID: 9775239 BACKGROUND

• Bar-Sela SM, Spierer O, Spierer A. Suture-related complications after congenital cataract surgery: Vicryl versus Mersilene sutures. J Cataract Refract Surg. 2007 Feb;33(2):301-4. doi: 10.1016/j.jcrs.2006.10.039.

  PMID: 17276274 BACKGROUND

• Melega MV, Dos Reis R, Lira RPC, de Oliveira DF, Arieta CEL, Alves M. Comparison Between Nylon and Polyglactin Sutures in Pediatric Cataract Surgery: A Randomized Controlled Clinical Trial. Front Med (Lausanne). 2021 Aug 27;8:700793. doi: 10.3389/fmed.2021.700793. eCollection 2021.

  PMID: 34513873 DERIVED

MeSH Terms

Conditions

Endophthalmitis; Cataract

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Eye Diseases; Lens Diseases

Central Study Contacts

Mathias Melega, MD

CONTACT

+55 19 997513150; mvmelega@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 23, 2019
• Study Start: January 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)