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Donors Predisposed by Corneal Collagen Cross-linking in Deep Lamellar Keratoplasty for the Patients With Keratoconus

Primary Purpose

Keratoconus

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Corneal donors predisposed by CXL
Corneal donors stored in corneal storage media
Sponsored by
Zhongshan Ophthalmic Center, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Corneal collagen cross-linking, Deep lamellar keratoplasty, Keratoconus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1.The best corrected visual quality of frame glasses is less than 0.3,2.The best corrected visual quality of rigid gas permeable contact lens (RGPCL) is less than 0.5/ RGPCL intolerance,3.The anterior corneal surface curvature >55D,4.The thinnest corneal thickness is less than 400 μm. One of the above four items is met Patients must be willing and able to return for scheduled follow-up examinations for 36 months after surgery Ages:over 18 Years Exclusion Criteria: History of intraocular surgery Severe dry eye Severe eyelid and conjunctival scar Loss of vision in contralateral eye Pregnant and lactating women

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-Sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CXL graft group

Conventional graft group

Arm Description

Corneal donors predisposed by CXL were used and the conventional DALK procedure was conducted in patients

Corneal donors stored in corneal storage media were used and the conventional DALK procedure was conducted in patients

Outcomes

Primary Outcome Measures

Simulated keratometry
Simulated keratometry measured by topography

Secondary Outcome Measures

Uncorrected distance visual acuity(UDVA)
UDVA (by using Snellen acuity charts) before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Corrected distance visual acuity (CDVA)
CDVA (by using Snellen acuity charts) before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Spherical equivalent (SE)
SE will be detected by combined optometry and phoroptor refractometer before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Manifest cylinder
Manifest cylinder will be detected by topography before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Corneal thickness
Corneal thickness of the thinnest area will be detected by Optical Coherence tomography before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Corneal endothelium cells
Corneal endothelium cells will be detected by confocal microscopy before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24 ,30 and 36 months after surgery
Intraocular pressure
Intraocular pressure was measured by non-contact tonometer before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24,30 and 36 months after surgery

Full Information

First Posted
June 2, 2023
Last Updated
June 14, 2023
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05905978
Brief Title
Donors Predisposed by Corneal Collagen Cross-linking in Deep Lamellar Keratoplasty for the Patients With Keratoconus
Official Title
Effectiveness and Safety of Donors Predisposed by Corneal Collagen Cross-linking in Deep Lamellar Keratoplasty for Treating the Patients With Keratoconus,A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The Study was designed as a randomized controlled study with the following objectives: To investigate whether use of donors predisposed by corneal collagen cross-linking (CXL) reduced myopic refractive errors for keratoconic eyes after Deep anterior lamellar keratoplasty (DALK). Overall 70 patients are planned to recruit., the patients were assigned to CXL graft group, in which corneal donors predisposed by CXL were used, or the conventional graft group, in which corneal donors stored in corneal storage media were used. The patients will be followed-up for 24 months.
Detailed Description
Keratoconus is a progressive ecstatic corneal disease characterized by forward bulging of the cornea, thinning of the corneal stroma, and irregular astigmatism. Corneal transplantation is necessary for patients with advanced keratoconus when spectacles and contact lens are inadequate for visual correction. Deep anterior lamellar keratoplasty is a conventional procedure for the treatment of keratoconus. However, DALK itself frequently causes abnormality of refraction, such as high degrees of astigmatism owing to irregular corneal surface for keratoconic eyes. Possible mechanisms of this progressive astigmatism include the recurrence of keratoconus in the grafts, progressive corneal thinning of the host cornea, or progressive misalignment of the graft- host interface over time, which prevents the achievement of satisfactory vision. Corneal collagen cross-linking is believed to have the ability to halt or decrease the progression of keratoconus. CXL treats keratoconus by strengthening corneal stromal collagen bonds with riboflavin activated by ultraviolet A (UVA), and is now a first-line treatment for progressive keratoconus. In this randomized controlled trial, we performed CXL on corneal donor tissues with the aim of achieving corneal stromal stiffening, thereafter DALK was conducted for the patients with advanced keratoconus using the tissues predisposed by CXL. The goal of this study is evaluating whether the strengthening grafts could reduce postoperative myopic refractive errors or arrest the progression of keratoconus for the patients with DALK.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
Corneal collagen cross-linking, Deep lamellar keratoplasty, Keratoconus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CXL graft group
Arm Type
Experimental
Arm Description
Corneal donors predisposed by CXL were used and the conventional DALK procedure was conducted in patients
Arm Title
Conventional graft group
Arm Type
Active Comparator
Arm Description
Corneal donors stored in corneal storage media were used and the conventional DALK procedure was conducted in patients
Intervention Type
Procedure
Intervention Name(s)
Corneal donors predisposed by CXL
Intervention Description
Corneal donors predisposed by CXL and DALK procedure was conducted in patients
Intervention Type
Procedure
Intervention Name(s)
Corneal donors stored in corneal storage media
Intervention Description
Corneal donors stored in corneal storage media and DALK procedure was conducted in patients
Primary Outcome Measure Information:
Title
Simulated keratometry
Description
Simulated keratometry measured by topography
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
Uncorrected distance visual acuity(UDVA)
Description
UDVA (by using Snellen acuity charts) before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Time Frame
36 months
Title
Corrected distance visual acuity (CDVA)
Description
CDVA (by using Snellen acuity charts) before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Time Frame
36 months
Title
Spherical equivalent (SE)
Description
SE will be detected by combined optometry and phoroptor refractometer before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Time Frame
36 months
Title
Manifest cylinder
Description
Manifest cylinder will be detected by topography before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Time Frame
36 months
Title
Corneal thickness
Description
Corneal thickness of the thinnest area will be detected by Optical Coherence tomography before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Time Frame
36 months
Title
Corneal endothelium cells
Description
Corneal endothelium cells will be detected by confocal microscopy before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24 ,30 and 36 months after surgery
Time Frame
36 months
Title
Intraocular pressure
Description
Intraocular pressure was measured by non-contact tonometer before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24,30 and 36 months after surgery
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.The best corrected visual quality of frame glasses is less than 0.3,2.The best corrected visual quality of rigid gas permeable contact lens (RGPCL) is less than 0.5/ RGPCL intolerance,3.The anterior corneal surface curvature >55D,4.The thinnest corneal thickness is less than 400 μm. One of the above four items is met Patients must be willing and able to return for scheduled follow-up examinations for 36 months after surgery Ages:over 18 Years Exclusion Criteria: History of intraocular surgery Severe dry eye Severe eyelid and conjunctival scar Loss of vision in contralateral eye Pregnant and lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Huang, MD, PHD
Phone
86-13682205425
Email
thuang@vip.163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojuan Dong, MD, PHD
Phone
86-13552338050
Email
qingerdong@126.com
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510070
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Jin
Phone
86-20-87334687
Email
lingjin41@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Donors Predisposed by Corneal Collagen Cross-linking in Deep Lamellar Keratoplasty for the Patients With Keratoconus

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