NCT02523950

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

2.3 years

First QC Date

July 7, 2015

Last Update Submit

April 27, 2016

Conditions

CataractCorneal Endothelial KeratopathyPhacoemulfisication+IOL ImplantationEndothelial Keratopathy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Staged group

ACTIVE COMPARATOR

Procedure/Surgery: Phacoemulsification + IOL implantation is performed in the first stage and DMEK is performed secondarily.

Procedure: Staged phacoemulsification and DMEKDevice: Intraocular lens (IOL) implantation

Combined group

ACTIVE COMPARATOR

Procedure/Surgery: Phacoemulsification + IOL implantation and DMEK are performed simultaneously.

Procedure: Combined phacoemulsification and DMEKDevice: Intraocular lens (IOL) implantation

Interventions

Staged phacoemulsification and DMEKPROCEDURE

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.

Staged group
Combined phacoemulsification and DMEKPROCEDURE

Routine phacoemulsification and DMEK are performed simultaneously.

Combined group
Intraocular lens (IOL) implantationDEVICE

After phacoemulsification and removal of all the lens material, a one-piece IOL is implanted into the lens capsule.

Combined groupStaged group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 19878827BACKGROUND

  • 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.

    PMID: 19139335BACKGROUND

  • 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.

    PMID: 22310081BACKGROUND

  • 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.

    PMID: 19548882BACKGROUND

Related Links

MeSH Terms

Conditions

Cataract

Interventions

Lenses, Intraocular

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and SuppliesProstheses and Implants

Study Officials

  • Yizhi Liu, M.D., Ph.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujuan Wang, M.D., Ph.D.

CONTACT

8618620717002yujuanwang2013@gmail.com

Ting Huang, M.D., Ph.D.

CONTACT

862087331540thuang@vip.163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

July 7, 2015

First Posted

August 14, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

April 29, 2016

Record last verified: 2016-04

Locations

CN(1)