Comparison of Compressed Continuous Suture and Conventional Suture in Pterygium Surgery

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

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

Study Overview

• Status: Recruiting
• Conditions: Primary Pterygium
• Intervention / Treatment: Procedure: Compression continuous suture with suture crimping; Procedure: Conventional Suture with suture crimping

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Wang, director; Phone Number: +86 022 23187165; Email: wangyan7143@vip.sina.com

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Recruiting
      • Tianjin Eye Hospital
      • Contact: yan wang, director; Phone Number: +862227313336; Email: wangyan7143@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Continuous suture group; Pterygium excision combined with autologous conjunctival transplantation was performed	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
Other: Intermittent suture group; Pterygium excision combined with autologous conjunctival transplantation was performed	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of surgery	The date on which the surgery was performed	Intraoperative
Implant stability	Whether the conjunctival graft is loose or detached	Postoperative follow-up was performed 1 day and 1 week after surgery
Postoperative discomfort	The degree of discomfort after surgery was evaluated using the VAS Pain score Scale	Postoperative follow-up was performed 1 day and 1 week after surgery
Stitch removal time	The date when the stitches were removed	Postoperative follow-up was performed 1 week after surgery

Collaborators and Investigators

• Sponsor: Tianjin Eye Hospital
• Investigators: Study Director: Yi Zhang, Tianjin Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Estimated): April 2, 2026
• Study Completion (Estimated): July 2, 2026

Study Registration Dates

• First Submitted: August 8, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Primary Pterygium; Compression Continuous Suture; Conventional Suture
• Other Study ID Numbers: zhangyi2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No