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

Minia University

Status: Unknown

Conditions: Keratoconus

Treatments: Other: corneal ring segments

Study type: Interventional

Funder types: Other

Identifiers

NCT05055349

324 : 11/2019

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 21 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

corneal collagen cross linking and intrastromal corneal keraring segments.

Active Comparator group

Description:

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

Treatment:

Other: corneal ring segments

toric phakic posterior IOL implantation and corneal collagen cross linking

Active Comparator group

Description:

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

Treatment:

Other: corneal ring segments