Staged and Combined Surgery for Cataract Patients With Corneal Endothelial Dysfunction

Cataract Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02523950
• Other study ID #: 2015MEKY047
• Status: Recruiting
• Phase: N/A
• First received: July 7, 2015
• Last updated: April 27, 2016
• Start date: March 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2016
• Source: Sun Yat-sen University
• Contact: Yujuan Wang, M.D., Ph.D.
• Phone: 8618620717002
• Email: yujuanwang2013[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee of Sun Yat-sen University
• Study type: Interventional

Clinical 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. Surgical and postoperative complications, visual acuity and corneal endothelial cell density are evaluated.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subjects are older than 18 years.

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:

1. Subjects have corneal stromal opacity and/or neovascularization.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Corneal Endothelial Keratopathy
• Endothelial Keratopathy
• Phacoemulfisication+IOL Implantation

Intervention

Procedure:
• 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.

Device:
• Intraocular lens (IOL) implantation
After phacoemulsification and removal of all the lens material, a one-piece IOL is implanted into the lens capsule.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Haotian Lin

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in visual acuity measured by Snellen chart		1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery	No
Primary	Change from baseline in central corneal thickness measured by anterior segment OCT		1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery	No
Primary	Change from baseline in endothelial cell density measured by corneal specular microscopy		1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery	No
Secondary	Change from baseline in endothelial graft attachment measured by anterior segment OCT		1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery	No
Secondary	Change from baseline in corneal transparency measured by slit-lamp microscopy		1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery	No

External Links

•   Zhongshan Ophthalmic Center website