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

NCT ID: NCT05055349

Last Updated: 2021-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-28

Study Completion Date

2021-11-22

Brief Summary

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

Detailed Description

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* 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.

Conditions

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Keratoconus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

corneal ring segments

Intervention Type OTHER

ring hard segments inserted within corneal stroma using femtolaser

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).

Group Type ACTIVE_COMPARATOR

corneal ring segments

Intervention Type OTHER

ring hard segments inserted within corneal stroma using femtolaser

Interventions

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corneal ring segments

ring hard segments inserted within corneal stroma using femtolaser

Intervention Type OTHER

Other Intervention Names

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toric phakic posterior IOL implantation/ corneal collagen cross linking

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Maher Khalafallah

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed Maher Khalafallah

Minya, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ahmed maher khalafallah

Role: CONTACT

01119094426

Facility Contacts

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ahmed maher khalafallah

Role: primary

01119094426

Other Identifiers

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324 : 11/2019

Identifier Type: -

Identifier Source: org_study_id

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