Staged and Combined Surgery for Cataract Patients With Corneal Endothelial Dysfunction

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.

Study Overview

• Status: Unknown
• Conditions: Cataract; Corneal Endothelial Keratopathy; Phacoemulfisication+IOL Implantation; Endothelial Keratopathy
• Intervention / Treatment: Procedure: Staged phacoemulsification and DMEK; Device: Intraocular lens (IOL) implantation; Procedure: Combined phacoemulsification and DMEK

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Yujuan Wang, M.D., Ph.D.; Phone Number: 8618620717002; Email: yujuanwang2013@gmail.com
      • Principal Investigator: Yizhi Liu, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Staged group; Procedure/Surgery: Phacoemulsification + IOL implantation is performed in the first stage and DMEK is performed secondarily.	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.; Device: Intraocular lens (IOL) implantation; After phacoemulsification and removal of all the lens material, a one-piece IOL is implanted into the lens capsule.
ACTIVE_COMPARATOR: Combined group; Procedure/Surgery: Phacoemulsification + IOL implantation 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.; Procedure: Combined phacoemulsification and DMEK; Routine phacoemulsification and DMEK are performed simultaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Haotian Lin
• Investigators: Principal Investigator: Yizhi Liu, M.D., Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

General 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.
• 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.

Helpful Links

• Zhongshan Ophthalmic Center website

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (ANTICIPATED): July 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: July 7, 2015
• First Submitted That Met QC Criteria: August 12, 2015
• First Posted (ESTIMATE): August 14, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): April 29, 2016
• Last Update Submitted That Met QC Criteria: April 27, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 2015MEKY047