Comparison of Compressed Continuous Suture and Conventional Suture in Pterygium Surgery

Official title

Comparison of Compression Continuous Suture Versus Conventional Suture for Autologous Conjunctival Implant Fixation in Primary Pterygium Surgery: a Randomized Controlled Trial

Overview

To compare the advantages and disadvantages of continuous suture with suture and conventional Suture in primary pterygium surgery for autologous conjunctival graft fixation

Detailed description

Pterygium is an abnormal fibrovascular tissue hyperplasia disease that occurs in the conjunctiva. The pterygium tissue can break through the limbus of the corneosclera and grow into the cornea, causing a foreign body sensation in the eyes, astigmatism, decreased vision, and even restricted eye movement. The purpose of surgical treatment for pterygium is not only to remove the diseased tissue, but more importantly, to reduce the recurrence of pterygium after surgery. Pterygium excision combined with simple autologous conjunctival transplantation is currently the most commonly used method for treating pterygium. The recurrence rate after autologous conjunctival epithelial tissue transplantation can be reduced to 5% to 30%.

As heterogenic substances, sutures can irritate the ocular surface, aggravate postoperative inflammatory reactions and conjunctival edema or hemorrhage, delay the repair of corneal wound epithelium, lead to abnormal ocular surface function, intensify postoperative discomfort, and induce hypertrophic granuloma or cysts, etc. Moreover, these adverse reactions can also induce the recurrence of pterygium (0-26%). In addition, the longer the time interval between suture removal, The greater the difficulty of removal, the more likely some of the knots may be completely buried under the conjunctiva. Therefore, in order to alleviate the adverse reactions caused by sutures and further simplify the operation of pterygium excision surgery, many attempts have been made at home and abroad to improve and innovate the method of graft fixation.

Interventions

• Procedure Compression continuous suture with suture crimping
  Pterygium excision combined with autologous conjunctival transplantation was performed, and the continuous suture method with pressure lines was adopted during the operation
• Procedure Conventional Suture with suture crimping
  Pterygium excision combined with autologous conjunctival transplantation was performed, and the traditional suture method was adopted during the operation

Primary outcome measures

• Duration of surgery [Time frame: Intraoperative]
• Implant stability [Time frame: Postoperative follow-up was performed 1 day and 1 week after surgery]
• Postoperative discomfort [Time frame: Postoperative follow-up was performed 1 day and 1 week after surgery]
• Stitch removal time [Time frame: Postoperative follow-up was performed 1 week after surgery]

Eligibility criteria

Inclusion criteria

• Diagnosis of primary pterygium according to diagnostic criteria;
• The pterygium head invades the cornea by 2-5mm;
• The patient agrees to the surgical treatment and signs the surgical consent form.

Exclusion criteria

• History of previous eye surgery;
• Have active ocular inflammatory lesions;
• recurrent and pseudopterygium;
• The patient refuses surgery or is unable to have regular follow-ups

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Factorial

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Tianjin Eye Hospital — Tianjin

Identifiers

NCT: NCT07244276 · zhangyi2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗