PterygiumNCT03204084
Assessment of Low-temperature Plasma Surgery System in Pterygium With Fibrin Glue and Conjunctival Autografts
An observational study of Pterygium, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial 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 . Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pterygium
- What is being tested?
- Low-temperature Plasma Surgery System
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- all cases are primary pterygium,a follow-up period of more than 3 months after surgery
Who cannot join
- no immunorelated disease, ocular surface disease, glaucoma, or eyelid disease. Patients with recurrent pterygium were excluded from the study.
About this study
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.
Read the detailed description
About Plasma It's confirmed that there are 3 physical forms of material existence in human living environment. They are solids, liquids and gass. And any physical form can exist in different states due to the influence of environmental factors. Plasma is the fourth form of material existence. It's composed of ionized conductive gases, including six typical particles, which are electron, positive ion, negative ion, atom or molecule at excited state, atom or molecule at ground state, and photon. Plasma is composed of those positive and negative charged particles and neutral particles, and is a kind of quasi-neutrality gas with collective behavior. It's called plasma when the total negative electric charge equals to the total positive electric charge. 99% visible materials in universe may exist in plasma state, including fixed stars. Plasma can be natural or man-made. For example, the lighting during rainstorms is plasma phenomena, because the high voltage difference between cloud layer and ground makes the air ionized. And neon light and fluorescent lamp are from man-made plasma. The gases in light tube are ionized into plasma state.
About Plasma Low temperature plasma (LTP) Surgery System Low temperature plasma (LTP) Surgery System(made in Chengdu Mechan Electronic Technology Co.,Ltd), which avoids causing burn injuries to patients, has been introducing into minimally invasive surgery. The mechanism by which this equipment stops bleeding is to directly occupy the injury with the formed blood clots, and different from the mechanism of the common electrical hemostatic devices that cauterize the tissues around the bleeding to stem the blood flow. At the same the Plasma Low temperature plasma (LTP) Surgery System has a some biological effects, such as ablation of the organization, this ablation function is generally not penetrating, and only has effect on the contact surface,which can safely handle with the tissue wound and prevent the planting and recurrence.
- Conditions
- Pterygium
- Being tested
- Low-temperature Plasma Surgery System
- Keywords
- pterygium,Low temperature plasma
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-temperature Plasma Surgery SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| the LTP group | Patients undergoing pterygium surgery with fibrin glue and conjunctival autografting and receiving Low-temperature Plasma Surgery System(LTP group), Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of Best-corrected visual acuity (BCVA),
Non-contact ocular pressure measuring instrument
Measured: 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)
OSS including five kinds of subjective sensory scale of foreign body sensation, burning sensation, visual fatigue, dryness and eye pain.
Measured: Before surgery,1-day, 1-week, 1-month, 3-month
conjunctival autograft inflammation
Inflammation Grade 0: No dilated corkscrew vessel in the graft Grade 1: 1 bright red, dilated corkscrew vessel crossing the graft-bed margin Grade 2: 2 bright red, dilated corkscrew vessels crossing the graft-bed margin Grade 3: three bright red, dilated corkscrew vessels crossing the graft-bed margin
Measured: 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)
the ocular surface inflammation assessed by the Oculus Keratograph○R5M (Oculus Optikgerate GmbH, Wetzlar, Germany)
Measured: 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
Digital slit-lamp photography was performed during each postoperative visit
Measured: 1-week, 1-month, 3-month
The recurrence
Digital slit-lamp photography was performed at 3-month
Measured: 3-month
slit-lamp examination
Corneal epithelium healing
Measured: Before surgery,1-week, 1-month
determination of intraocular pressure
Non-contact tonometer
Measured: Before surgery, 3-month
The changes of Patient's subjective discomfort evaluated in terms of the visual analogue scale(VAS) by a questionnaire method
Visual Simulation Scoring (VAS): The method is more sensitive and comparable. The specific approach is: on the paper to draw a 10 cm horizontal line, one end of the horizontal line is 0, that painless; the other end is 10, that pain; the middle part of the different degrees of pain. Let the patient according to self-feeling in the horizontal line on a mark, that the degree of pain
Measured: Before surgery,1-day, 1-week, 1-month, 3-month
The subconjunctival haemorrhage (SCH)
Subconjunctival haemorrhage
Measured: 1-day, 1-week
graft stability according to scoring scale
Grade 0: None Grade 1: 25% of the size of the graft Grade 2: 50% of the size of the graft Grade 3: 75% of the size of the graft Grade 4: Haemorrhage involving the entire graft (no subconjunctival vessels visible
Grade 4: >3 bright red, dilated corkscrew vessels crossing the graft-bed margin Graft stability Grade 0: All four sides of the graft margin are well apposed Grade 1: Gaping/displacement of one side of the graft-bed junction Grade 2: Gaping/displacement of two sides of the graft-bed junction Grade 3: Gaping/displacement of three sides of the graft-bed junction Grade 4: Graft completely displaced from the bed
Measured: 1-day, 1-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study startAug 2016
- Primary completionFeb 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204084
- Sponsor's protocol ID
- 2016011
- Status last verified
- Jun 2017
- First submitted
- 19 Jun 2017
- Last updated
- 29 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Low-temperature Plasma Surgery System in Pterygium With Fibrin Glue and Conjunctival Autografts
- ClinicalTrials.gov ID
- NCT03204084
- Acronym / sponsor ID
- 2016011
- Conditions
- Pterygium
- Keywords
- pterygium,Low temperature plasma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 29 Jun 2017 (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.
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.
Detailed description
About Plasma It's confirmed that there are 3 physical forms of material existence in human living environment. They are solids, liquids and gass. And any physical form can exist in different states due to the influence of environmental factors. Plasma is the fourth form of material existence. It's composed of ionized conductive gases, including six typical particles, which are electron, positive ion, negative ion, atom or molecule at excited state, atom or molecule at ground state, and photon. Plasma is composed of those positive and negative charged particles and neutral particles, and is a kind of quasi-neutrality gas with collective behavior. It's called plasma when the total negative electric charge equals to the total positive electric charge. 99% visible materials in universe may exist in plasma state, including fixed stars. Plasma can be natural or man-made. For example, the lighting during rainstorms is plasma phenomena, because the high voltage difference between cloud layer and ground makes the air ionized. And neon light and fluorescent lamp are from man-made plasma. The gases in light tube are ionized into plasma state.
About Plasma Low temperature plasma (LTP) Surgery System Low temperature plasma (LTP) Surgery System(made in Chengdu Mechan Electronic Technology Co.,Ltd), which avoids causing burn injuries to patients, has been introducing into minimally invasive surgery. The mechanism by which this equipment stops bleeding is to directly occupy the injury with the formed blood clots, and different from the mechanism of the common electrical hemostatic devices that cauterize the tissues around the bleeding to stem the blood flow. At the same the Plasma Low temperature plasma (LTP) Surgery System has a some biological effects, such as ablation of the organization, this ablation function is generally not penetrating, and only has effect on the contact surface,which can safely handle with the tissue wound and prevent the planting and recurrence.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the LTP group | – | Device: Low-temperature Plasma Surgery SystemPatients undergoing pterygium surgery with fibrin glue and conjunctival autografting and receiving Low-temperature Plasma Surgery System(LTP group), |
| 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) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- all cases are primary pterygium,a follow-up period of more than 3 months after surgery
Key exclusion criteria (1 listed)
- no immunorelated disease, ocular surface disease, glaucoma, or eyelid disease. Patients with recurrent pterygium were excluded from the study.
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 |
|---|---|---|
| Low-temperature Plasma Surgery SystemIn pterygium surgery with fibrin glue(FG) and conjunctival autograft we use Low-temperature Plasma Surgery System(LTP)do the ablation of tissue and hemostasis. | Device | the LTP group |
Primary outcome
The changes of Best-corrected visual acuity (BCVA),
Time frame: Before surgery,1-day, 1-week, 1-month, 3-month
Non-contact ocular pressure measuring instrument
10 secondary outcomes
The changes of Patient's subjective discomfort evaluated in terms of the ocular symptom scores(OSS)
Time frame: Before surgery,1-day, 1-week, 1-month, 3-month
conjunctival autograft inflammation
Time frame: 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)
Time frame: 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
Time frame: 1-week, 1-month, 3-month
The recurrence
Time frame: 3-month
slit-lamp examination
Time frame: Before surgery,1-week, 1-month
determination of intraocular pressure
Time frame: Before surgery, 3-month
The changes of Patient's subjective discomfort evaluated in terms of the visual analogue scale(VAS) by a questionnaire method
Time frame: Before surgery,1-day, 1-week, 1-month, 3-month
The subconjunctival haemorrhage (SCH)
Time frame: 1-day, 1-week
graft stability according to scoring scale
Time frame: 1-day, 1-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pterygium, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of Best-corrected visual acuity (BCVA), (time frame: Before surgery,1-day, 1-week, 1-month, 3-month). 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 29 Jun 2017.