Staged and Combined Surgery for Cataract Patients With Corneal Endothelial Dysfunction
NCT ID: NCT02523950
Last Updated: 2016-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2015-03-31
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Staged group
Procedure/Surgery: Phacoemulsification + IOL implantation is performed in the first stage and DMEK is performed secondarily.
Staged phacoemulsification and DMEK
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.
Intraocular lens (IOL) implantation
After phacoemulsification and removal of all the lens material, a one-piece IOL is implanted into the lens capsule.
Combined group
Procedure/Surgery: Phacoemulsification + IOL implantation and DMEK are performed simultaneously.
Combined phacoemulsification and DMEK
Routine phacoemulsification and DMEK are performed simultaneously.
Intraocular lens (IOL) implantation
After phacoemulsification and removal of all the lens material, a one-piece IOL is implanted into the lens capsule.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Staged phacoemulsification and DMEK
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 DMEK
Routine phacoemulsification and DMEK are performed simultaneously.
Intraocular lens (IOL) implantation
After phacoemulsification and removal of all the lens material, a one-piece IOL is implanted into the lens capsule.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subjects have corneal endothelial dysfunction combined with cataract.
3. Subjects have mild to moderate cortical and/or nuclear cataract.
4. Subjects are able and willing to provide informed consent.
Exclusion Criteria
2. Subjects have other intraocular disease that disturbs visual rehabilitation.
3. Subjects have corneal infection, perforation or scarring.
4. Subjects are pregnant.
5. Subjects have concurrent disease that could confound the response to therapy.
6. Subjects are unlikely to comply with the protocol or likely to be lost to follow-up.
7. Subjects have known hypersensitivity or intolerance to the proposed therapy.
8. Subjects use concomitant therapy that affects either tear function or ocular surface integrity.
9. 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.
19 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Haotian Lin
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Haotian Lin
M.D., Ph.D.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yizhi Liu, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yujuan Wang, M.D., Ph.D.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Huang 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.
Luo 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.
Xia 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.
Related Links
Access external resources that provide additional context or updates about the study.
Zhongshan Ophthalmic Center website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015MEKY047
Identifier Type: -
Identifier Source: org_study_id