Perioperative Pain ExperiencesNCT03049163
Comparison the Topical Anesthesia and Retrobulbar Anesthesia for 27-gauge Vitrectomy for Vitreous Floaters
A study testing vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)] in people with Perioperative Pain Experiences, run by Lin Zhong at 1 site in China.
Trial summary
Routine anesthesia methods for vitrectomy surgery include retrobulbar and peribulbar anesthesia. However, both methods have potential complications that can vary from minor to severe. Vitrectomy surgery for vitreous floaters is widely considered straighter forward than other vitreoretinal surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Pain Experiences
- What is being tested?
- vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Jun 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who is going to undergo vitrectomy surgery for vitreous floaters
- age>18 years
- patients who are willing to participate in this study
Who cannot join
- patients who had vitrectomy surgery before
- patients who had penetrating ocular trauma before
Trial locations and contacts
1 site in 1 country.
Zhong Lin, Doctor contact
China1 site, 1 recruiting
- Recruiting
Ethics Committee of The Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
Peiqiu Gu, bachelor, +8613695896445, gupeiqiu@126.com
About this study
Routine anesthesia methods for vitrectomy surgery include retrobulbar and peribulbar anesthesia. However, both methods have potential complications that can vary from minor to severe.
Vitrectomy surgery for vitreous floaters is widely considered straighter forward than other vitreoretinal surgeries.
Hence, the investigators compared the effect of topical anesthesia (with eye drops) and retrobulbar anesthesia for 27-gauge par plana vitrectomy for symptomatic vitreous floaters.
- Conditions
- Perioperative Pain Experiences
- Being tested
- vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]Drug
Also called 0.5% proparacaine HCL (Alcaine®, Alcon, TX)
to observe the anesthesia effect of topical anesthesia of 27-gauge vitrectomy for vitreous floaters
| Study group | Role | What they receive |
|---|---|---|
| vitrectomy under retrobulbar anesthesia | Other | 27-gauge vitrectomy for vitreous floaters under traditional retrobulbar anesthesia Receives: Drug: vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)] |
| vitrectomy under topical anesthesia | Experimental | 27-gauge vitrectomy for vitreous floaters under topical anesthesia Receives: Drug: vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Pain Scale
Measured: 2 hour post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startOct 2016
- Primary completionMar 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perioperative Pain ExperiencesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lin Zhong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lin Zhong, The Eye Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049163
- Sponsor's protocol ID
- KYQD131101-01
- Status last verified
- Feb 2017
- First submitted
- 28 Jan 2017
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu RH, Zhang R, Lin Z, Liang QH, Moonasar N. A comparison between topical and retrobulbar anesthesia in 27-gauge vitrectomy for vitreous floaters: a randomized controlled trial. BMC Ophthalmol. 2018 Jul 7;18(1):164. doi: 10.1186/s12886-018-0838-7.
PubMed 29981573Lin Z, Zhang R, Liang QH, Lin K, Xiao YS, Moonasar N, Wu RH. Surgical Outcomes of 27-Gauge Pars PLana Vitrectomy for Symptomatic Vitreous Floaters. J Ophthalmol. 2017;2017:5496298. doi: 10.1155/2017/5496298. Epub 2017 Nov 29.
PubMed 29318039
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Topical Anesthesia and Retrobulbar Anesthesia for 27-gauge Vitrectomy for Vitreous Floaters
- ClinicalTrials.gov ID
- NCT03049163
- Acronym / sponsor ID
- KYQD131101-01
- Conditions
- Perioperative Pain Experiences
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lin ZhongUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- 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.
Routine anesthesia methods for vitrectomy surgery include retrobulbar and peribulbar anesthesia. However, both methods have potential complications that can vary from minor to severe.
Vitrectomy surgery for vitreous floaters is widely considered straighter forward than other vitreoretinal surgeries.
Hence, the investigators compared the effect of topical anesthesia (with eye drops) and retrobulbar anesthesia for 27-gauge par plana vitrectomy for symptomatic vitreous floaters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitrectomy under retrobulbar anesthesia | Other | Drug: vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]27-gauge vitrectomy for vitreous floaters under traditional retrobulbar anesthesia |
| vitrectomy under topical anesthesia | Experimental | Drug: vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]27-gauge vitrectomy for vitreous floaters under topical anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who is going to undergo vitrectomy surgery for vitreous floaters
- age>18 years
- patients who are willing to participate in this study
Key exclusion criteria (2 listed)
- patients who had vitrectomy surgery before
- patients who had penetrating ocular trauma before
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 |
|---|---|---|
| vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]Also: 0.5% proparacaine HCL (Alcaine®, Alcon, TX)to observe the anesthesia effect of topical anesthesia of 27-gauge vitrectomy for vitreous floaters | Drug | vitrectomy under retrobulbar anesthesia, vitrectomy under topical anesthesia |
Primary outcome
Visual Analogue Pain Scale
Time frame: 2 hour post-operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Derived from this study: PubMed 29981573Wu RH, Zhang R, Lin Z, Liang QH, Moonasar N. A comparison between topical and retrobulbar anesthesia in 27-gauge vitrectomy for vitreous floaters: a randomized controlled trial. BMC Ophthalmol. 2018 Jul 7;18(1):164. doi: 10.1186/s12886-018-0838-7.
- Derived from this study: PubMed 29318039Lin Z, Zhang R, Liang QH, Lin K, Xiao YS, Moonasar N, Wu RH. Surgical Outcomes of 27-Gauge Pars PLana Vitrectomy for Symptomatic Vitreous Floaters. J Ophthalmol. 2017;2017:5496298. doi: 10.1155/2017/5496298. Epub 2017 Nov 29.
- Individual participant dataSharing planned: No
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.
Zhong Lin, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)] in people with Perioperative Pain Experiences, run by Lin Zhong 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 2 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: status not confirmed, as of the sponsor's last update on 9 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhong Lin, Doctor (+8613758475525), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Pain Scale (time frame: 2 hour post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03049163, which also lists 2 linked publications.
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 9 Feb 2017.