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Effect of Intracorneal Ring Segments on Posterior Corneal Tomography in Eyes With Keratoconus

Primary Purpose

Keratoconus, Keratoconus Posterior

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Intracorneal ring segment implantation
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring keratoconus, intracorneal ring segments, posterior corneal surface

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Patients with keratoconus grade 1, 2 or 3 according to Amsler-Krumeich classification.
  • Best corrected visual acuity (BCVA) ≤ 6/12.
  • Mean front keratometric (K) readings ≤ 60 diopters (D).
  • Corneal thickness ≥ 400 µm at the location of ICRS implantation.
  • Clear central cornea

Exclusion Criteria

  • Central corneal opacity.
  • Previous corneal laser refractive surgery.
  • Previous corneal collagen cross linking.
  • Previous cataract surgery or phakic IOL implantation.
  • History of herpetic keratitis.
  • History of acute hydrops.
  • Ocular comorbidities such as cataract, glaucoma or retinal disease.
  • Systemic diseases affecting healing process such as autoimmune or connective tissue disease.

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

Intracorneal ring segments are implanted for treatment of keratoconus, and posterior corneal surface is assessed preoperatively and postoperatively.

Outcomes

Primary Outcome Measures

Posterior corneal astigmatism
It is measured by corneal imaging device preoperatively and postoperatively

Secondary Outcome Measures

Visual Acuity
It is measured by Snellen Chart Acuity

Full Information

First Posted
January 31, 2021
Last Updated
February 5, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04748198
Brief Title
Effect of Intracorneal Ring Segments on Posterior Corneal Tomography in Eyes With Keratoconus
Official Title
Effect of Intracorneal Ring Segments on Posterior Corneal Tomography in Eyes With Keratoconus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 10, 2018 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams 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
Our purpose is to analyze the changes induced in the posterior corneal surface in patients implanted with intracorneal ring segments for treatment of keratoconus. Patients are assessed with corneal imaging device preoperatively and at 1, 3, 6 and 12 months postoperatively.
Detailed Description
Procedure: Femtosecond laser assisted implantation of intracorneal ring segments in keratoconus patients Uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), refraction, keratometric (K) readings of the anterior and posterior surface, corneal asphericity (Q value) of the anterior and posterior surface, and anterior and posterior elevations are evaluated using a corneal imaging device preoperatively and at 1, 3, 6 and 12 months after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Keratoconus Posterior
Keywords
keratoconus, intracorneal ring segments, posterior corneal surface

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Intracorneal ring segments are implanted for treatment of keratoconus, and posterior corneal surface is assessed preoperatively and postoperatively.
Intervention Type
Procedure
Intervention Name(s)
Intracorneal ring segment implantation
Intervention Description
Surgical procedure for keratoconus treatment. A tunnel is created in the corneal stroma with femtosecond laser and ring segments are implanted in the corneal stroma
Primary Outcome Measure Information:
Title
Posterior corneal astigmatism
Description
It is measured by corneal imaging device preoperatively and postoperatively
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Visual Acuity
Description
It is measured by Snellen Chart Acuity
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients with keratoconus grade 1, 2 or 3 according to Amsler-Krumeich classification. Best corrected visual acuity (BCVA) ≤ 6/12. Mean front keratometric (K) readings ≤ 60 diopters (D). Corneal thickness ≥ 400 µm at the location of ICRS implantation. Clear central cornea Exclusion Criteria Central corneal opacity. Previous corneal laser refractive surgery. Previous corneal collagen cross linking. Previous cataract surgery or phakic IOL implantation. History of herpetic keratitis. History of acute hydrops. Ocular comorbidities such as cataract, glaucoma or retinal disease. Systemic diseases affecting healing process such as autoimmune or connective tissue disease.
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22410615
Citation
Sogutlu E, Pinero DP, Kubaloglu A, Alio JL, Cinar Y. Elevation changes of central posterior corneal surface after intracorneal ring segment implantation in keratoconus. Cornea. 2012 Apr;31(4):387-95. doi: 10.1097/ICO.0b013e31822481df.
Results Reference
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PubMed Identifier
29256982
Citation
Muftuoglu O, Aydin R, Kilic Muftuoglu I. Persistence of the Cone on the Posterior Corneal Surface Affecting Corneal Aberration Changes After Intracorneal Ring Segment Implantation in Patients With Keratoconus. Cornea. 2018 Mar;37(3):347-353. doi: 10.1097/ICO.0000000000001492.
Results Reference
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PubMed Identifier
23806046
Citation
Rho CR, Na KS, Yoo YS, Pandey C, Park CW, Joo CK. Changes in anterior and posterior corneal parameters in patients with keratoconus after intrastromal corneal-ring segment implantation. Curr Eye Res. 2013 Aug;38(8):843-50. doi: 10.3109/02713683.2013.788723. Epub 2013 Apr 22.
Results Reference
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Effect of Intracorneal Ring Segments on Posterior Corneal Tomography in Eyes With Keratoconus

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