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

Primary Purpose

Keratoconus

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

corneal ring segments

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

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

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

Sites / Locations

Ahmed Maher KhalafallahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

corneal collagen cross linking and intrastromal corneal keraring segments.

toric phakic posterior IOL implantation and corneal collagen cross linking

Arm Description

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

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

Outcomes

Primary Outcome Measures

pentacam readings

a device that read topometric corneal data and other data

Secondary Outcome Measures

Full Information

NCT ID

NCT05055349

First Posted

March 25, 2021

Last Updated

September 21, 2021

Sponsor

Minia University

1. Study Identification

Unique Protocol Identification Number

NCT05055349

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 28, 2019 (Actual)

Primary Completion Date

November 15, 2021 (Anticipated)

Study Completion Date

November 22, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

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.

6. Conditions and Keywords

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

Keratoconus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

corneal collagen cross linking and intrastromal corneal keraring segments.

Arm Type

Active Comparator

Arm Description

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

Arm Title

toric phakic posterior IOL implantation and corneal collagen cross linking

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

corneal ring segments

Other Intervention Name(s)

toric phakic posterior IOL implantation/ corneal collagen cross linking

Intervention Description

ring hard segments inserted within corneal stroma using femtolaser

Primary Outcome Measure Information:

Title

pentacam readings

Description

a device that read topometric corneal data and other data

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ahmed maher khalafallah

Phone

01119094426

drahmedmaher1988@gmail.com

Facility Information:

Facility Name

Ahmed Maher Khalafallah

City

Minya

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ahmed maher khalafallah

Phone

01119094426

drahmedmaher1988@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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