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

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05055349
• Other study ID #: 324 : 11/2019
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2019
• Est. completion date: November 22, 2021

Study information

• Verified date: September 2021
• Source: Minia University
• Contact: ahmed maher khalafallah
• Phone: 01119094426
• Email: drahmedmaher1988[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 22, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

Other:
• corneal ring segments
ring hard segments inserted within corneal stroma using femtolaser

Locations

Country	Name	City	State
Egypt	Ahmed Maher Khalafallah	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pentacam readings	a device that read topometric corneal data and other data	1 month