CataractNCT03976791
A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision
A study testing enlarged internal incision and regular 2.2mm incision in people with Cataract, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
Objective and Principle: To evaluate whether enlarging the incision can reduce corneal complications associated with phacoemulsification with regular 2.2 mm incision. The aim of this study: To evaluate whether the technique of enlarging internal incision could reduce the incidence of descemet membrane detachment after… Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- enlarged internal incision and regular 2.2mm incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 30 Dec 2019
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age-related cataract patients
- Age from 65 to 90
- The diameter of pupil after mydriasis is more than 6 mm
- LOCS III nuclear grade ≥4
- Corneal endothelial cell count > 1500 cells/mm2
- Phacoemulsification and intraocular lens implantation are planned
- Agree to participate in this study and sign informed consent
Who cannot join
- History of ocular trauma
- Anterior segment lesions (exfoliation syndrome, suspension ligament injury or relaxation, corneal and iris lesions, glaucoma)
- Other ocular diseases that impair visual function, such as optic neuropathy, uveitis and ocular tumors
- History of Ophthalmic Surgery
- Intraoperative and Postoperative Complications
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510060
Yizhi Liu, Doctor
About this study
Objective and Principle: To evaluate whether enlarging the incision can reduce corneal complications associated with phacoemulsification with regular 2.2 mm incision.
The aim of this study: To evaluate whether the technique of enlarging internal incision could reduce the incidence of descemet membrane detachment after 2.2 mm incision phacoemulsification.
Secondary outcome: To evaluate whether the technique of enlarged internal incision can reduce other corneal complications such as corneal edema and astigmatism after 2.2 mm incision phacoemulsification.
Study Design: A prospective randomized controlled study
- Conditions
- Cataract
- Being tested
- enlarged internal incision, regular 2.2mm incision
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enlarged internal incisionProcedure or surgery
enlarging the internal incision about 0.4mm
regular 2.2mm incisionProcedure or surgery
2.2mm microincision coaxial phacoemulsification
| Study group | Role | What they receive |
|---|---|---|
| Enlarged internal incision | Experimental | enlarged the internal incision about 0.4mm Receives: Procedure: enlarged internal incision |
| Regular 2.2mm incision | Placebo comparator | regular 2.2mm corneal incision for microincision coaxial phacoemulsification Receives: Procedure: regular 2.2mm incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
descemet membrane detachment(DMD)
DMD at the incision observed by anterior segment optical coherence tomography
Measured: postoperative 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start1 Jul 2019 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yizhi Liu, Doctor, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976791
- Sponsor's protocol ID
- 2019KYPJ078
- Status last verified
- Jun 2019
- First submitted
- 4 Jun 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision
- ClinicalTrials.gov ID
- NCT03976791
- Acronym / sponsor ID
- 2019KYPJ078
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 6 Jun 2019 (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.
Objective and Principle: To evaluate whether enlarging the incision can reduce corneal complications associated with phacoemulsification with regular 2.2 mm incision.
The aim of this study: To evaluate whether the technique of enlarging internal incision could reduce the incidence of descemet membrane detachment after 2.2 mm incision phacoemulsification.
Secondary outcome: To evaluate whether the technique of enlarged internal incision can reduce other corneal complications such as corneal edema and astigmatism after 2.2 mm incision phacoemulsification.
Study Design: A prospective randomized controlled study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enlarged internal incision | Experimental | Procedure: enlarged internal incisionenlarged the internal incision about 0.4mm |
| Regular 2.2mm incision | Placebo comparator | Procedure: regular 2.2mm incisionregular 2.2mm corneal incision for microincision coaxial phacoemulsification |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age-related cataract patients
- Age from 65 to 90
- The diameter of pupil after mydriasis is more than 6 mm
- LOCS III nuclear grade ≥4
- Corneal endothelial cell count > 1500 cells/mm2
Key exclusion criteria (5 listed)
- History of ocular trauma
- Anterior segment lesions (exfoliation syndrome, suspension ligament injury or relaxation, corneal and iris lesions, glaucoma)
- Other ocular diseases that impair visual function, such as optic neuropathy, uveitis and ocular tumors
- History of Ophthalmic Surgery
- Intraoperative and Postoperative 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 |
|---|---|---|
| enlarged internal incisionenlarging the internal incision about 0.4mm | Procedure or surgery | Enlarged internal incision |
| regular 2.2mm incision2.2mm microincision coaxial phacoemulsification | Procedure or surgery | Regular 2.2mm incision |
Primary outcome
descemet membrane detachment(DMD)
Time frame: postoperative 1 week
DMD at the incision observed by anterior segment optical coherence tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
Related trials for Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
Cataract, Endothelial Cell Density
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.
Yizhi Liu, Doctor principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enlarged internal incision and regular 2.2mm incision in people with Cataract, run by Zhongshan Ophthalmic Center, Sun Yat-sen University 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 7 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 14 Jun 2019. 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. Some participants in this study may receive a placebo. 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 Yizhi Liu, Doctor (87330475, liuyizh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
descemet membrane detachment(DMD) (time frame: postoperative 1 week). 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 14 Jun 2019.