CataractNCT01824927
Pain Expression in the Perioperative Period of Cataract Surgery
A study testing First eye (FE), Second eye (SE) and Steroids eye drops in people with Cataract and Surgery, run by Evidence Based Cataract Study Group at 1 site in China.
Trial summary
Patients having cataract extraction in the second eye under topical anesthesia with monitored anesthesia care often report increased pain and awareness relative to the first surgery in the fellow eye, despite similar operative and anesthetic conditions. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- What is being tested?
- First eye (FE), Second eye (SE) and Steroids eye drops
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to May 2013
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age-related cataract patients aged 50 years or older able to give informed consent undergoing cataract surgery;
- Pupil dilation ≧7 mm after mydrisis;
- VA prognosis ≧6/12
Who cannot join
- Unable to give informed consent;
- Patients with history of ocular pathology or diabetic retinopathy;
- Patients with traumatic, subluxated and posterior polar cataract;
- Patients had other ocular surgery (not cataract surgery) in the past 6 months;
- Patients with significant intra-operative complications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye and ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
Peng Zhou, M.D., +86-18801871108, drzhoupeng@gmail.com
Peng Zhou, M.D.
About this study
Patients having cataract extraction in the second eye under topical anesthesia with monitored anesthesia care often report increased pain and awareness relative to the first surgery in the fellow eye, despite similar operative and anesthetic conditions. The purpose of this study is to investigate the pathogenesis of this phenomenon.
- Being tested
- First eye (FE), Second eye (SE), Steroids eye drops
- Medical subject headings
- Cataract, Eye Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First eye (FE)Procedure or surgery
Phacoemulsification cataract extraction surgery
Second eye (SE)Procedure or surgery
Phacoemulsification cataract extraction surgery
Steroids eye dropsDrug
Use steroids eye drops to decrease the pain.
| Study group | Role | What they receive |
|---|---|---|
| First eye (FE) | Active comparator | Phacoemulsification cataract extraction surgery of first eye Receives: Procedure: First eye (FE); Drug: Steroids eye drops |
| Second eye (SE) | Active comparator | Phacoemulsification cataract extraction surgery of second eye Receives: Procedure: Second eye (SE); Drug: Steroids eye drops |
| Steroids eye drops | Experimental | Dexamethasone eye drop, 1 drop, qid, for 3 days before surgery Receives: Procedure: First eye (FE); Procedure: Second eye (SE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain level
Post operative pain level recorded on a VAS (0-10) at rest for the first three days after cataract surgery.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evidence Based Cataract Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng ZHOU, Evidence Based Cataract Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824927
- Sponsor's protocol ID
- EBCS001
- Other IDs
- NSFC81200669
- Status last verified
- Apr 2013
- First submitted
- 2 Apr 2013
- Last updated
- 5 Apr 2013
- Results posted
- No
Publications
Zhu XJ, Wolff D, Zhang KK, He WW, Sun XH, Lu Y, Zhou P. Molecular Inflammation in the Contralateral Eye After Cataract Surgery in the First Eye. Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5566-73. doi: 10.1167/iovs.15-16531.
PubMed 26305528
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Expression in the Perioperative Period of Cataract Surgery
- ClinicalTrials.gov ID
- NCT01824927
- Acronym / sponsor ID
- EBCS001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Evidence Based Cataract Study GroupUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2013 (estimated)
- First posted
- 5 Apr 2013 (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.
Patients having cataract extraction in the second eye under topical anesthesia with monitored anesthesia care often report increased pain and awareness relative to the first surgery in the fellow eye, despite similar operative and anesthetic conditions. The purpose of this study is to investigate the pathogenesis of this phenomenon.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First eye (FE) | Active comparator | Procedure: First eye (FE), Drug: Steroids eye dropsPhacoemulsification cataract extraction surgery of first eye |
| Second eye (SE) | Active comparator | Procedure: Second eye (SE), Drug: Steroids eye dropsPhacoemulsification cataract extraction surgery of second eye |
| Steroids eye drops | Experimental | Procedure: First eye (FE), Procedure: Second eye (SE)Dexamethasone eye drop, 1 drop, qid, for 3 days before surgery |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age-related cataract patients aged 50 years or older able to give informed consent undergoing cataract surgery;
- Pupil dilation ≧7 mm after mydrisis;
- VA prognosis ≧6/12
Key exclusion criteria (5 listed)
- Unable to give informed consent;
- Patients with history of ocular pathology or diabetic retinopathy;
- Patients with traumatic, subluxated and posterior polar cataract;
- Patients had other ocular surgery (not cataract surgery) in the past 6 months;
- Patients with significant intra-operative complications
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 |
|---|---|---|
| First eye (FE)Phacoemulsification cataract extraction surgery | Procedure or surgery | First eye (FE), Steroids eye drops |
| Second eye (SE)Phacoemulsification cataract extraction surgery | Procedure or surgery | Second eye (SE), Steroids eye drops |
| Steroids eye dropsUse steroids eye drops to decrease the pain. | Drug | First eye (FE), Second eye (SE) |
Primary outcome
Post operative pain level
Time frame: 3 days
Post operative pain level recorded on a VAS (0-10) at rest for the first three days after cataract surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
- Derived from this study: PubMed 26305528Zhu XJ, Wolff D, Zhang KK, He WW, Sun XH, Lu Y, Zhou P. Molecular Inflammation in the Contralateral Eye After Cataract Surgery in the First Eye. Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5566-73. doi: 10.1167/iovs.15-16531.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First eye (FE), Second eye (SE) and Steroids eye drops in people with Cataract and Surgery, run by Evidence Based Cataract Study Group 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 5 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 5 Apr 2013. 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 Peng ZHOU, M.D. (+86-18801871108, drzhoupeng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain level (time frame: 3 days). 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 NCT01824927, which also lists 1 linked publication.
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 5 Apr 2013.