Intrastromal Corneal Ring Segments and Toric Phakic Posterior Intra-ocular Lenses Implantation in Keratoconus

Sponsor
Minia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05055349
Collaborator
(none)
40
1
2
23.8
1.7

Study Details

Study Description

Brief Summary

To compare visual and refractive measurements of intrastromal corneal ring segments versus toric phakic posterior intra-ocular lenses implantation in keratoconus

Condition or Disease Intervention/Treatment Phase
  • Other: corneal ring segments
N/A

Detailed Description

  • The study is a prospective comparative interventional case series. It will be conducted in Minia university hospital and Roaa Laser Vision Correction Center.

  • Fourty eyes will be evenly allocated into two groups:

Group (A): 20 eyes will undergo corneal collagen cross linking (epithelium off) 1 month after Femtosecond laser assisted intrastromal corneal keraring segments.

Group (B): 20 eyes will undergo toric phakic posterior IOL implantation 1 year after corneal collagen cross linking (epithelium off).

• An informed written consent to be involved in the study will be obtained from each patient.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
"Comparison Between Intrastromal Corneal Ring Segments and Toric Phakic Posterior Intra-ocular Lenses Implantation in Keratoconus"
Actual Study Start Date :
Nov 28, 2019
Anticipated Primary Completion Date :
Nov 15, 2021
Anticipated Study Completion Date :
Nov 22, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: corneal collagen cross linking and intrastromal corneal keraring segments.

20 eyes will undergo corneal collagen cross linking (epithelium off) 1 month after Femtosecond laser assisted intrastromal corneal keraring segments

Other: corneal ring segments
ring hard segments inserted within corneal stroma using femtolaser
Other Names:
  • toric phakic posterior IOL implantation/ corneal collagen cross linking
  • Active Comparator: toric phakic posterior IOL implantation and corneal collagen cross linking

    20 eyes will undergo toric phakic posterior IOL implantation 1 year after corneal collagen cross linking (epithelium off).

    Other: corneal ring segments
    ring hard segments inserted within corneal stroma using femtolaser
    Other Names:
  • toric phakic posterior IOL implantation/ corneal collagen cross linking
  • Outcome Measures

    Primary Outcome Measures

    1. pentacam readings [1 month]

      a device that read topometric corneal data and other data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Keratoconus grade I to III according to the Amsler-Krumeich classification
    Exclusion Criteria:
    • Acute hydrops or grade IV keratoconus

    • Any ocular diseases or surgeries

    • Corneal thickness less than 400 µm at the thinnest corneal point, and at least 450 µm at the incision site for ICRS group

    • Corneal pacities

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ahmed Maher Khalafallah Minya Egypt

    Sponsors and Collaborators

    • Minia University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Maher Khalafallah, Principal Investigator, Minia University
    ClinicalTrials.gov Identifier:
    NCT05055349
    Other Study ID Numbers:
    • 324 : 11/2019
    First Posted:
    Sep 24, 2021
    Last Update Posted:
    Sep 24, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 24, 2021