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

Study Overview
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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.

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

Conditions
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Keratoconus

Intervention / Treatment
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* Other: corneal ring segments


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: corneal collagen cross linking and intrastromal corneal keraring segments.<br>20 eyes will undergo corneal collagen cross linking (epithelium off) 1 month after Femtosecond laser assisted intrastromal corneal keraring segments | Other: corneal ring segments<br>* ring hard segments inserted within corneal stroma using femtolaser<br>* Other names: toric phakic posterior IOL implantation/ corneal collagen cross linking;|
| Active Comparator: toric phakic posterior IOL implantation and corneal collagen cross linking<br>20 eyes will undergo toric phakic posterior IOL implantation 1 year after corneal collagen cross linking (epithelium off). | Other: corneal ring segments<br>* ring hard segments inserted within corneal stroma using femtolaser<br>* Other names: toric phakic posterior IOL implantation/ corneal collagen cross linking;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pentacam readings | a device that read topometric corneal data and other data | 1 month |