CataractNCT02523950
Staged and Combined Surgery for Cataract Patients With Corneal Endothelial Dysfunction
A study testing Staged phacoemulsification and DMEK, Combined phacoemulsification and DMEK and Intraocular lens (IOL) implantation in people with Cataract and Corneal Endothelial Keratopathy, run by Haotian Lin at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of staged and combined phacoemulsification with intraocular lens implantation and Descemet membrane endothelial keratoplasty (DMEK) to treat cataract patients with corneal endothelial dysfunction. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Cataract, Corneal Endothelial Keratopathy, Phacoemulfisication+IOL Implantation
- What is being tested?
- Staged phacoemulsification and DMEK, Combined phacoemulsification and DMEK and Intraocular lens (IOL) implantation
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Dec 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are older than 18 years.
- Subjects have corneal endothelial dysfunction combined with cataract.
- Subjects have mild to moderate cortical and/or nuclear cataract.
- Subjects are able and willing to provide informed consent.
Who cannot join
- Subjects have corneal stromal opacity and/or neovascularization.
- Subjects have other intraocular disease that disturbs visual rehabilitation.
- Subjects have corneal infection, perforation or scarring.
- Subjects are pregnant.
- Subjects have concurrent disease that could confound the response to therapy.
- Subjects are unlikely to comply with the protocol or likely to be lost to follow-up.
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- Subjects have known hypersensitivity or intolerance to the proposed therapy.
- Subjects use concomitant therapy that affects either tear function or ocular surface integrity.
- Subjects have had surgical or other manipulation of the eye that could confound the outcome parameters or interfere with the mechanism of action of the proposed intervention to be studied.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Yujuan Wang, M.D., Ph.D., 8618620717002, yujuanwang2013@gmail.com
Yizhi Liu, M.D., Ph.D.
About this study
Official title: Evaluation of Staged and Combined Phacoemulsification With Intraocular Lens (IOL) Implantation and Descemet Membrane Endothelial Keratoplasty (DMEK) for Cataract Patients With Corneal Endothelial Dysfunction
The purpose of this study is to evaluate the safety and efficacy of staged and combined phacoemulsification with intraocular lens implantation and Descemet membrane endothelial keratoplasty (DMEK) to treat cataract patients with corneal endothelial dysfunction. Surgical and postoperative complications, visual acuity and corneal endothelial cell density are evaluated.
Read the detailed description
The prospective, randomized, controlled study involves the enrollment of cataract patients with corneal endothelial dysfunction. All the patients will be randomly assigned with equal probability to the following two groups: 1. Staged group: phacoemulsification + IOL implantation is performed individually and DMEK is performed secondarily according to the corneal status of patients. During cataract surgery, viscoelastic materials and anterior lens capsule are used to protect the compromised corneal endothelium during phacoemulsification. After phacoemulsification and removal of all the lens material, a one-piece foldable IOL is implanted into the lens capsule. 2: Combined group: phacoemulsification + IOL implantation and DMEK is performed simultaneously. Standard procedures of phacoemulsification + IOL implantation are the same as in the staged group.
Patients enrolled into the study will be followed for one year and will have study visits at 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after each surgery.
- Conditions
- Cataract, Corneal Endothelial Keratopathy, Phacoemulfisication+IOL Implantation, Endothelial Keratopathy
- Being tested
- Staged phacoemulsification and DMEK, Combined phacoemulsification and DMEK, Intraocular lens (IOL) implantation
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staged phacoemulsification and DMEKProcedure or surgery
Stage 1. Phacoemulsification is performed individually. During phacoemulsification, viscoelastic materials and anterior lens capsule are used to protect corneal endothelial cells.
Stage 2. DMEK is performed secondarily according to the corneal status of patients.
Combined phacoemulsification and DMEKProcedure or surgery
Routine phacoemulsification and DMEK are performed simultaneously.
Intraocular lens (IOL) implantationDevice
After phacoemulsification and removal of all the lens material, a one-piece IOL is implanted into the lens capsule.
| Study group | Role | What they receive |
|---|---|---|
| Staged group | Active comparator | Procedure/Surgery: Phacoemulsification + IOL implantation is performed in the first stage and DMEK is performed secondarily. Receives: Procedure: Staged phacoemulsification and DMEK; Device: Intraocular lens (IOL) implantation |
| Combined group | Active comparator | Procedure/Surgery: Phacoemulsification + IOL implantation and DMEK are performed simultaneously. Receives: Procedure: Combined phacoemulsification and DMEK; Device: Intraocular lens (IOL) implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in visual acuity measured by Snellen chart
Measured: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
Change from baseline in central corneal thickness measured by anterior segment OCT
Measured: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
Change from baseline in endothelial cell density measured by corneal specular microscopy
Measured: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
Secondary outcomes (2)
Change from baseline in endothelial graft attachment measured by anterior segment OCT
Measured: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
Change from baseline in corneal transparency measured by slit-lamp microscopy
Measured: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haotian Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Yizhi Liu, M.D., Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523950
- Sponsor's protocol ID
- 2015MEKY047
- Status last verified
- Apr 2016
- First submitted
- 7 Jul 2015
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang Y, Xia Y, Zeng M, Liu X, Luo L, Chen B, Liu Y, Liu Y. Torsional ultrasound efficiency under different vacuum levels in different degrees of nuclear cataract. J Cataract Refract Surg. 2009 Nov;35(11):1941-5. doi: 10.1016/j.jcrs.2009.05.055.
PubMed 19878827Huang T, Wang Y, Ji J, Gao N, Chen J. Deep lamellar endothelial keratoplasty for iridocorneal endothelial syndrome in phakic eyes. Arch Ophthalmol. 2009 Jan;127(1):33-6. doi: 10.1001/archophthalmol.2008.537.
PubMed 19139335Luo L, Lin H, He M, Congdon N, Yang Y, Liu Y. Clinical evaluation of three incision size-dependent phacoemulsification systems. Am J Ophthalmol. 2012 May;153(5):831-839.e2. doi: 10.1016/j.ajo.2011.10.034. Epub 2012 Feb 4.
PubMed 22310081Xia Y, Liu X, Luo L, Zeng Y, Cai X, Zeng M, Liu Y. Early changes in clear cornea incision after phacoemulsification: an anterior segment optical coherence tomography study. Acta Ophthalmol. 2009 Nov;87(7):764-8. doi: 10.1111/j.1755-3768.2008.01333.x. Epub 2009 Jun 22.
PubMed 19548882
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Staged and Combined Phacoemulsification With Intraocular Lens (IOL) Implantation and Descemet Membrane Endothelial Keratoplasty (DMEK) for Cataract Patients With Corneal Endothelial Dysfunction
- ClinicalTrials.gov ID
- NCT02523950
- Acronym / sponsor ID
- 2015MEKY047
- Conditions
- Cataract, Corneal Endothelial Keratopathy, Phacoemulfisication+IOL Implantation, Endothelial Keratopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Haotian LinUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Aug 2015 (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.
The purpose of this study is to evaluate the safety and efficacy of staged and combined phacoemulsification with intraocular lens implantation and Descemet membrane endothelial keratoplasty (DMEK) to treat cataract patients with corneal endothelial dysfunction. Surgical and postoperative complications, visual acuity and corneal endothelial cell density are evaluated.
Detailed description
The prospective, randomized, controlled study involves the enrollment of cataract patients with corneal endothelial dysfunction. All the patients will be randomly assigned with equal probability to the following two groups: 1. Staged group: phacoemulsification + IOL implantation is performed individually and DMEK is performed secondarily according to the corneal status of patients. During cataract surgery, viscoelastic materials and anterior lens capsule are used to protect the compromised corneal endothelium during phacoemulsification. After phacoemulsification and removal of all the lens material, a one-piece foldable IOL is implanted into the lens capsule. 2: Combined group: phacoemulsification + IOL implantation and DMEK is performed simultaneously. Standard procedures of phacoemulsification + IOL implantation are the same as in the staged group.
Patients enrolled into the study will be followed for one year and will have study visits at 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after each surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staged group | Active comparator | Procedure: Staged phacoemulsification and DMEK, Device: Intraocular lens (IOL) implantationProcedure/Surgery: Phacoemulsification + IOL implantation is performed in the first stage and DMEK is performed secondarily. |
| Combined group | Active comparator | Procedure: Combined phacoemulsification and DMEK, Device: Intraocular lens (IOL) implantationProcedure/Surgery: Phacoemulsification + IOL implantation and DMEK are performed simultaneously. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects are older than 18 years.
- Subjects have corneal endothelial dysfunction combined with cataract.
- Subjects have mild to moderate cortical and/or nuclear cataract.
- Subjects are able and willing to provide informed consent.
Key exclusion criteria (9 listed)
- Subjects have corneal stromal opacity and/or neovascularization.
- Subjects have other intraocular disease that disturbs visual rehabilitation.
- Subjects have corneal infection, perforation or scarring.
- Subjects are pregnant.
- Subjects have concurrent disease that could confound the response to therapy.
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 |
|---|---|---|
| Staged phacoemulsification and DMEKStage 1. Phacoemulsification is performed individually. During phacoemulsification, viscoelastic materials and anterior lens capsule are used to protect corneal endothelial cells. Stage 2. DMEK is performed secondarily according to the corneal status of patients. | Procedure or surgery | Staged group |
| Combined phacoemulsification and DMEKRoutine phacoemulsification and DMEK are performed simultaneously. | Procedure or surgery | Combined group |
| Intraocular lens (IOL) implantationAfter phacoemulsification and removal of all the lens material, a one-piece IOL is implanted into the lens capsule. | Device | Combined group, Staged group |
Primary outcome
Change from baseline in visual acuity measured by Snellen chart
Time frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
Change from baseline in central corneal thickness measured by anterior segment OCT
Time frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
Change from baseline in endothelial cell density measured by corneal specular microscopy
Time frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
2 secondary outcomes
Change from baseline in endothelial graft attachment measured by anterior segment OCT
Time frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
Change from baseline in corneal transparency measured by slit-lamp microscopy
Time frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Background: PubMed 19878827Wang Y, Xia Y, Zeng M, Liu X, Luo L, Chen B, Liu Y, Liu Y. Torsional ultrasound efficiency under different vacuum levels in different degrees of nuclear cataract. J Cataract Refract Surg. 2009 Nov;35(11):1941-5. doi: 10.1016/j.jcrs.2009.05.055.
- Background: PubMed 19139335Huang T, Wang Y, Ji J, Gao N, Chen J. Deep lamellar endothelial keratoplasty for iridocorneal endothelial syndrome in phakic eyes. Arch Ophthalmol. 2009 Jan;127(1):33-6. doi: 10.1001/archophthalmol.2008.537.
- Background: PubMed 22310081Luo L, Lin H, He M, Congdon N, Yang Y, Liu Y. Clinical evaluation of three incision size-dependent phacoemulsification systems. Am J Ophthalmol. 2012 May;153(5):831-839.e2. doi: 10.1016/j.ajo.2011.10.034. Epub 2012 Feb 4.
- Background: PubMed 19548882Xia Y, Liu X, Luo L, Zeng Y, Cai X, Zeng M, Liu Y. Early changes in clear cornea incision after phacoemulsification: an anterior segment optical coherence tomography study. Acta Ophthalmol. 2009 Nov;87(7):764-8. doi: 10.1111/j.1755-3768.2008.01333.x. Epub 2009 Jun 22.
- Zhongshan Ophthalmic Center websiteLink provided by the sponsor.
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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, M.D., Ph.D. 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 Staged phacoemulsification and DMEK, Combined phacoemulsification and DMEK and Intraocular lens (IOL) implantation in people with Cataract and Corneal Endothelial Keratopathy, run by Haotian Lin 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 4 inclusion and 9 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 29 Apr 2016. 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 Yujuan Wang, M.D., Ph.D. (8618620717002, yujuanwang2013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in visual acuity measured by Snellen chart (time frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery). The study lists 3 primary outcomes in all. 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 NCT02523950, which also lists 4 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 29 Apr 2016.