Assessment of Low-temperature Plasma Surgery System in Pterygium With Fibrin Glue and Conjunctival Autografts

NCT03204084 | Completed

• 1 other identifier: 2016011
• Study Type: observational
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pterygium is a wing-shaped fibrovascular tissue that has proliferated onto the cornea. Ultraviolet radiation and hot, dusty, windy, dry, smoky environments are regarded as risk factors for pterygium . Surgical removal is the treatment of choice, and surgical wound intraoperative and inflammatory response postoperative have been considered two of the most significant factors that can increase the recurrence rate of pterygium. Low-Temperature Plasma Surgery System(LTP), avoids causing burn injuries to patients, has been introducing into minimally invasive surgery. The mechanism by which this equipment stop bleeding and abolish tissue is to directly occupy the injury with the formed blood clots, plasma flows close the vessel and plasma active particles cause physical and chemical reactions with tissue. The different levels of energy density of plasma can affect the bacteria, cells and cancer cells and even to death, therefore it is widely used in the disinfection of medical devices, dental root canal therapy, skin disease treatment and surgical wound disinfection. Whether it's possible to apply the advantages and benefits of plasma technology in ophthalmic surgery? Like pterygium surgery? However, there is no research to answer until now. In this study, the investigators retrospectively observed the efficacy, postoperative discomfort, inflammation, complications, and recurrence rates in a group of patients for whose LTP was used in pterygium excision and wound hemostasis. The investigators Observe the clinical benefits of LTP in pterygium surgery and find the facilitates and problems it need to be addressed reasonably.

Conditions

Pterygium

Keywords

pterygium,Low temperature plasma

Outcome Measures

Primary Outcomes (1)

• The changes of Best-corrected visual acuity (BCVA),

  Non-contact ocular pressure measuring instrument

  Before surgery,1-day, 1-week, 1-month, 3-month

Secondary Outcomes (10)

• The changes of Patient's subjective discomfort evaluated in terms of the ocular symptom scores(OSS)

  Before surgery,1-day, 1-week, 1-month, 3-month

• conjunctival autograft inflammation

  1-day, 1-week

• The changes of the ocular surface inflammation assessed by the Oculus Keratograph○R5M (Oculus Optikgerate GmbH, Wetzlar, Germany), with temporal conjunctival hyperaemia index(TCHI)

  Before surgery, 1-week, 1-month, 3-month

• The postoperative complications were examined, including dehiscence, dislocation, sclera wound healing defects, granuloma and high intraocular pressure

  1-week, 1-month, 3-month

• The recurrence

  3-month

Study Arms (2)

the LTP group

Patients undergoing pterygium surgery with fibrin glue and conjunctival autografting and receiving Low-temperature Plasma Surgery System(LTP group),

Device: Low-temperature Plasma Surgery System

the control group

Patients undergoing pterygium surgery with fibrin glue and conjunctival autografting and receiving the conventional method using surgical micro knife and ophthalmic hemostasis(control group)

Interventions

Low-temperature Plasma Surgery System DEVICE

In pterygium surgery with fibrin glue(FG) and conjunctival autograft we use Low-temperature Plasma Surgery System(LTP)do the ablation of tissue and hemostasis.

the LTP group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Fifty-six patients participated in the study. The LTP group consisted of 28 patients (6men) with a mean age±SD of 58.79±1.65 years (range, 42-75 years). The control group consisted of 28 patients (9men) with a mean age±SD of 59.79±1.35 years (range, 41-80years). There were no significant differences in age, gender or eye.

You may qualify if:

• all cases are primary pterygium,a follow-up period of more than 3 months after surgery

You may not qualify if:

• no immunorelated disease, ocular surface disease, glaucoma, or eyelid disease. Patients with recurrent pterygium were excluded from the study.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 29, 2017
• Study Start: August 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: April 1, 2017
• Last Updated: June 29, 2017

Record last verified: 2017-06