Back to results

Staged and Combined Surgery for Cataract Patients With Corneal Endothelial Dysfunction

Primary Purpose

Cataract, Corneal Endothelial Keratopathy, Phacoemulfisication+IOL Implantation

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Staged phacoemulsification and DMEK

Combined phacoemulsification and DMEK

Intraocular lens (IOL) implantation

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Staged group

Combined group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in visual acuity measured by Snellen chart

Change from baseline in central corneal thickness measured by anterior segment OCT

Change from baseline in endothelial cell density measured by corneal specular microscopy

Secondary Outcome Measures

Change from baseline in endothelial graft attachment measured by anterior segment OCT

Change from baseline in corneal transparency measured by slit-lamp microscopy

Full Information

NCT ID

NCT02523950

First Posted

July 7, 2015

Last Updated

April 27, 2016

Sponsor

Haotian Lin

1. Study Identification

Unique Protocol Identification Number

NCT02523950

Brief Title

Staged and Combined Surgery for Cataract Patients With Corneal Endothelial Dysfunction

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

July 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Haotian Lin

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Staged group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Combined group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Staged phacoemulsification and DMEK

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Combined phacoemulsification and DMEK

Intervention Description

Routine phacoemulsification and DMEK are performed simultaneously.

Intervention Type

Device

Intervention Name(s)

Intraocular lens (IOL) implantation

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in visual acuity measured by Snellen chart

Time Frame