CataractNCT04014699
Clinical Evaluation of Modified 2.2mm Microincision Phacoemulsification for Age-related Cataract
A study testing modified 2.2mm microincision and conventional 2.2mm microincision in people with Cataract, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
This study is a single-center, parallel-group, randomized controlled trial with the following objectives: to compare the incidence of post-operative descemet membrane detachment (DMD) in phacoemulsification surgery between modified and conventional 2.2mm microincision. 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?
- modified 2.2mm microincision and conventional 2.2mm microincision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2019to 22 Jan 2020
- 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
- Aged-related cataract patients between 65 and 90 years ;
- Lens nuclear opalescence grade ≥4.0 on the Lens Opacities Classification System III (LOCS III);
- Scheduled for phacoemulsification combined with intraocular lens implantation.
- The number of corneal endothelial cells > 1500cells/mm2.
- Dilated pupil diameter ≥6mm
Who cannot join
- A history of ophthalmic trauma or surgery;
- Other ophthalmic diseases such as glaucoma, uveitis, high myopia;
- Ocular factors that would make surgery challenging or dangerous, including but not limited to small pupil, shallow anterior chamber, etc.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, 510060
About this study
This study is a single-center, parallel-group, randomized controlled trial with the following objectives: to compare the incidence of post-operative descemet membrane detachment (DMD) in phacoemulsification surgery between modified and conventional 2.2mm microincision.
Read the detailed description
2.2mm incision is considered an ideal incision size in phacoemulsification. However, DMD is a common and serious complication in 2.2mm microincision phacoemulsification for hard nucleus age-related cataract. DMD is originated from the incision in the operation. How to construct the appropriate incision shape and size for reducing the occurrence of DMD is an important problem to be solved urgently in phacoemulsification surgery.
The investigators found that enlarging the internal incision could increase the range of motion of surgical instruments and reduce the friction of instruments to incision. Therefore，the incidence of DMD would be reduced. The investigators developed this technique, modified 2.2mm incision, to reduce the incidence of incision-site DMD and not to increase other incision related complications.
In this trial, the investigators aim to compare modified and conventional 2.2mm incision with regard to safety and efficacy in reducing the incidence of DMD.
- Conditions
- Cataract
- Being tested
- modified 2.2mm microincision, conventional 2.2mm microincision
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified 2.2mm microincisionProcedure or surgery
enlarging the internal incision about 0.4mm for conventional 2.2mm coaxial microincision phacoemulsification
conventional 2.2mm microincisionProcedure or surgery
conventional 2.2mm coaxial microincision phacoemulsification
| Study group | Role | What they receive |
|---|---|---|
| modified 2.2mm micoincision | Experimental | Not described Receives: Procedure: modified 2.2mm microincision |
| conventional 2.2mm microincision | Active comparator | Not described Receives: Procedure: conventional 2.2mm microincision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DMD at postoperative day 1
Incidence of incision-site descemet membrane detachment observed by anterior segment OCT at postoperative day 1
Measured: postoperative day 1
Secondary outcomes (6)
maximal incision thickness
maximal incision thickness measured by anterior segment OCT at postoperative day 1, day 7, month 1, month 3
Measured: postoperative day 1, day 7, month 1, month 3
surgical induced-astigmatism
surgical induced-astigmatism was calculated at each postoperative visit using the following equation: K2 = [K1 2 + K32 -2 K1 K3 cos (2θ3 -2θ1)]1/2
Measured: postoperative day 1, day 7, month 1, month 3
the length of DMD
the length of incision-site descemet membrane detachment measured by anterior segment OCT at postoperative day 1, day 7, month 1, month 3
Measured: postoperative day 1, day 7, month 1, month 3
Best corrected visual acuity (BCVA)
Best corrected visual acuity (BCVA) is evaluated with an ETDRS chart at each postoperative visit
Measured: postoperative day 1, day 7, month 1, month 3
modulation transfer function (MTF)-cut off
modulation transfer function (MTF)-cut off measured by itrace at each postoperative visit
Measured: postoperative day 1, day 7, month 1, month 3
central cornea endothelial cell loss
Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density.
Measured: postoperative day 1, day 7, month 1, month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start22 Jul 2019
- Primary completion22 Oct 2019
- Study completion22 Jan 2020
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yizhi Liu, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014699
- Sponsor's protocol ID
- 2019KYPJ091
- Status last verified
- Sep 2020
- First submitted
- 6 Jul 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dai Y, Liu Z, Wang W, Han X, Jin L, Chen X, Jin G, Wang L, Zhang E, Qu B, Liu J, Congdon N, He M, Luo L, Liu Y. Incidence of Incision-Related Descemet Membrane Detachment Using Phacoemulsification With Trapezoid vs Conventional 2.2-mm Clear Corneal Incision: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Nov 1;139(11):1228-1234. doi: 10.1001/jamaophthalmol.2021.4148.
PubMed 34647960
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Modified 2.2mm Microincision Phacoemulsification for Age-related Cataract
- ClinicalTrials.gov ID
- NCT04014699
- Acronym / sponsor ID
- 2019KYPJ091
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 10 Jul 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.
This study is a single-center, parallel-group, randomized controlled trial with the following objectives: to compare the incidence of post-operative descemet membrane detachment (DMD) in phacoemulsification surgery between modified and conventional 2.2mm microincision.
Detailed description
2.2mm incision is considered an ideal incision size in phacoemulsification. However, DMD is a common and serious complication in 2.2mm microincision phacoemulsification for hard nucleus age-related cataract. DMD is originated from the incision in the operation. How to construct the appropriate incision shape and size for reducing the occurrence of DMD is an important problem to be solved urgently in phacoemulsification surgery.
The investigators found that enlarging the internal incision could increase the range of motion of surgical instruments and reduce the friction of instruments to incision. Therefore，the incidence of DMD would be reduced. The investigators developed this technique, modified 2.2mm incision, to reduce the incidence of incision-site DMD and not to increase other incision related complications.
In this trial, the investigators aim to compare modified and conventional 2.2mm incision with regard to safety and efficacy in reducing the incidence of DMD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified 2.2mm micoincision | Experimental | Procedure: modified 2.2mm microincision |
| conventional 2.2mm microincision | Active comparator | Procedure: conventional 2.2mm microincision |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Aged-related cataract patients between 65 and 90 years ;
- Lens nuclear opalescence grade ≥4.0 on the Lens Opacities Classification System III (LOCS III);
- Scheduled for phacoemulsification combined with intraocular lens implantation.
- The number of corneal endothelial cells > 1500cells/mm2.
- Dilated pupil diameter ≥6mm
Key exclusion criteria (3 listed)
- A history of ophthalmic trauma or surgery;
- Other ophthalmic diseases such as glaucoma, uveitis, high myopia;
- Ocular factors that would make surgery challenging or dangerous, including but not limited to small pupil, shallow anterior chamber, 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 |
|---|---|---|
| modified 2.2mm microincisionenlarging the internal incision about 0.4mm for conventional 2.2mm coaxial microincision phacoemulsification | Procedure or surgery | modified 2.2mm micoincision |
| conventional 2.2mm microincisionconventional 2.2mm coaxial microincision phacoemulsification | Procedure or surgery | conventional 2.2mm microincision |
Primary outcome
Incidence of DMD at postoperative day 1
Time frame: postoperative day 1
Incidence of incision-site descemet membrane detachment observed by anterior segment OCT at postoperative day 1
6 secondary outcomes
maximal incision thickness
Time frame: postoperative day 1, day 7, month 1, month 3
surgical induced-astigmatism
Time frame: postoperative day 1, day 7, month 1, month 3
the length of DMD
Time frame: postoperative day 1, day 7, month 1, month 3
Best corrected visual acuity (BCVA)
Time frame: postoperative day 1, day 7, month 1, month 3
modulation transfer function (MTF)-cut off
Time frame: postoperative day 1, day 7, month 1, month 3
central cornea endothelial cell loss
Time frame: postoperative day 1, day 7, month 1, month 3
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 16 Sep 2020.
- Derived from this study: PubMed 34647960Dai Y, Liu Z, Wang W, Han X, Jin L, Chen X, Jin G, Wang L, Zhang E, Qu B, Liu J, Congdon N, He M, Luo L, Liu Y. Incidence of Incision-Related Descemet Membrane Detachment Using Phacoemulsification With Trapezoid vs Conventional 2.2-mm Clear Corneal Incision: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Nov 1;139(11):1228-1234. doi: 10.1001/jamaophthalmol.2021.4148.
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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.
Yizhi Liu, PhD 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 modified 2.2mm microincision and conventional 2.2mm microincision 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 5 inclusion and 3 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 16 Sep 2020. 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?
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?
Incidence of DMD at postoperative day 1 (time frame: postoperative day 1). 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 NCT04014699, 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 16 Sep 2020.