Cortical Senile CataractTFAPNCT02238015
Tear Film Evaluation After Phacoemulsification
An observational study of Cortical Senile Cataract, run by Zheng Qian at 1 site in China.
Trial summary
To compare tear film differences between surgical eyes and nonsurgical eyes in patients who had cataract surgery by phacoemulsification in one eye. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Cortical Senile Cataract
- What is being tested?
- cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Mar 2015
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 60 eyes from 30 age-related cataract participants underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye and the other eye without surgery history
Who may be able to join
- age-related cataract without surgery history and dry eye symptoms history
Who cannot join
- diseases influencing tear secretion (such as Sjögren syndrome, Steve-Johnson syndrome, diabetes, thyroid disease, etc.); history of ocular surgeries or nuclear hardness IV and V, which required the use of larger phacoemulsification energy; use of drugs that affect tear secretion and stability (such as glaucoma medications, artificial tears, corticosteroid drugs, etc.); or presence of ocular diseases (such as Pterygium, blepharitis, uveitis, glaucoma, lacrimal apparatus, etc.).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wenzhou Medical University
Wenzhou, Zhejiang, 325027
Qian Zheng, MD, 18367839685, zq15.04@163.com
About this study
Official title: To Investigate Tear Film Change After Phacoemulsification With SS-OCT
To compare tear film differences between surgical eyes and nonsurgical eyes in patients who had cataract surgery by phacoemulsification in one eye.
Read the detailed description
All participants granted their written informed consent to participate in the research protocol.
- Conditions
- Cortical Senile Cataract
- Being tested
- cataract surgery
- Keywords
- cataract ,tear film,SS-OCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryProcedure or surgery
All patients underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye
| Study group | Role | What they receive |
|---|---|---|
| surgery group | patients underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye Receives: Procedure: cataract surgery | |
| control group | patients' other eye that did not have surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phacoemulsification influence on the postoperative tear functions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startOct 2013
- Primary completionMay 2014
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cortical Senile 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zheng Qian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zheng Qian, Wenzhou Medical University
- Investigators
- Qian Zheng, MD, Principal investigator, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238015
- Sponsor's protocol ID
- WZMC2013BNZYJ
- Acronym
- TFAP
- Status last verified
- Sep 2014
- First submitted
- 28 Aug 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate Tear Film Change After Phacoemulsification With SS-OCT
- ClinicalTrials.gov ID
- NCT02238015
- Acronym / sponsor ID
- TFAP / WZMC2013BNZYJ
- Conditions
- Cortical Senile Cataract
- Keywords
- cataract ,tear film,SS-OCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zheng QianUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Mar 2015 (estimated)
- First posted
- 12 Sep 2014 (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.
To compare tear film differences between surgical eyes and nonsurgical eyes in patients who had cataract surgery by phacoemulsification in one eye.
Detailed description
All participants granted their written informed consent to participate in the research protocol.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery group | – | Procedure: cataract surgerypatients underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye |
| control group | – | –patients' other eye that did not have surgery |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 eyes from 30 age-related cataract participants underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye and the other eye without surgery history
Key inclusion criteria (1 listed)
- age-related cataract without surgery history and dry eye symptoms history
Key exclusion criteria (1 listed)
- diseases influencing tear secretion (such as Sjögren syndrome, Steve-Johnson syndrome, diabetes, thyroid disease, etc.); history of ocular surgeries or nuclear hardness IV and V, which required the use of larger phacoemulsification energy; use of drugs that affect tear secretion and stability (such as glaucoma medications, artificial tears, corticosteroid drugs, etc.); or presence of ocular diseases (such as Pterygium, blepharitis, uveitis, glaucoma, lacrimal apparatus, etc.).
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 |
|---|---|---|
| cataract surgeryAll patients underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye | Procedure or surgery | surgery group |
Primary outcome
Phacoemulsification influence on the postoperative tear functions
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
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.
Qian Zheng, MD principal investigator
Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cortical Senile Cataract, run by Zheng Qian 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 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: status not confirmed, as of the sponsor's last update on 12 Sep 2014. 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 Qian Zheng, MD (18367839685, zq15.04@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phacoemulsification influence on the postoperative tear functions (time frame: 1 year). 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 12 Sep 2014; AzTrials last refreshed its copy on 31 Oct 2026.