Primary PterygiumNCT07244276
Comparison of Compressed Continuous Suture and Conventional Suture in Pterygium Surgery
A study testing Compression continuous suture with suture crimping and Conventional Suture with suture crimping in people with Primary Pterygium, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
To compare the advantages and disadvantages of continuous suture with suture and conventional Suture in primary pterygium surgery for autologous conjunctival graft fixation Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Pterygium
- What is being tested?
- Compression continuous suture with suture crimping and Conventional Suture with suture crimping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2024to 2 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Eye Hospital
Tianjin, Tianjin Municipality
yan wang, director, +862227313336, wangyan7143@vip.sina.com
About this study
Official title: 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
Read the 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.
- Conditions
- Primary Pterygium
- Being tested
- Compression continuous suture with suture crimping, Conventional Suture with suture crimping
- Keywords
- Primary Pterygium, Compression Continuous Suture, Conventional Suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression continuous suture with suture crimpingProcedure or surgery
Pterygium excision combined with autologous conjunctival transplantation was performed, and the continuous suture method with pressure lines was adopted during the operation
Conventional Suture with suture crimpingProcedure or surgery
Pterygium excision combined with autologous conjunctival transplantation was performed, and the traditional suture method was adopted during the operation
| Study group | Role | What they receive |
|---|---|---|
| Continuous suture group | Other | Pterygium excision combined with autologous conjunctival transplantation was performed Receives: Procedure: Compression continuous suture with suture crimping |
| Intermittent suture group | Other | Pterygium excision combined with autologous conjunctival transplantation was performed Receives: Procedure: Conventional Suture with suture crimping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of surgery
The date on which the surgery was performed
Measured: Intraoperative
Implant stability
Whether the conjunctival graft is loose or detached
Measured: 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
Measured: Postoperative follow-up was performed 1 day and 1 week after surgery
Stitch removal time
The date when the stitches were removed
Measured: Postoperative follow-up was performed 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start2 Apr 2024
- Primary completion2 Apr 2026 (estimated)
- Study completion2 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary PterygiumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Zhang, Study director, Tianjin Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244276
- Sponsor's protocol ID
- zhangyi2025
- Status last verified
- Apr 2025
- First submitted
- 8 Aug 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Compression Continuous Suture Versus Conventional Suture for Autologous Conjunctival Implant Fixation in Primary Pterygium Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07244276
- Acronym / sponsor ID
- zhangyi2025
- Conditions
- Primary Pterygium
- Keywords
- Primary Pterygium, Compression Continuous Suture, Conventional Suture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 2 Apr 2026 (estimated)
- Study completion
- 2 Jul 2026 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous suture group | Other | Procedure: Compression continuous suture with suture crimpingPterygium excision combined with autologous conjunctival transplantation was performed |
| Intermittent suture group | Other | Procedure: Conventional Suture with suture crimpingPterygium excision combined with autologous conjunctival transplantation was performed |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression continuous suture with suture crimpingPterygium excision combined with autologous conjunctival transplantation was performed, and the continuous suture method with pressure lines was adopted during the operation | Procedure or surgery | Continuous suture group |
| Conventional Suture with suture crimpingPterygium excision combined with autologous conjunctival transplantation was performed, and the traditional suture method was adopted during the operation | Procedure or surgery | Intermittent suture group |
Primary outcome
Duration of surgery
Time frame: Intraoperative
The date on which the surgery was performed
Implant stability
Time frame: Postoperative follow-up was performed 1 day and 1 week after surgery
Whether the conjunctival graft is loose or detached
Postoperative discomfort
Time frame: Postoperative follow-up was performed 1 day and 1 week after surgery
The degree of discomfort after surgery was evaluated using the VAS Pain score Scale
Stitch removal time
Time frame: Postoperative follow-up was performed 1 week after surgery
The date when the stitches were removed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi Zhang study director
Tianjin Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression continuous suture with suture crimping and Conventional Suture with suture crimping in people with Primary Pterygium, run by Tianjin Eye Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Wang, director (23187165 ext. +86 022, wangyan7143@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of surgery (time frame: Intraoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.