NCT05055349

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2021

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

March 25, 2021

Last Update Submit

September 21, 2021

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • pentacam readings

    a device that read topometric corneal data and other data

    1 month

Study Arms (2)

corneal collagen cross linking and intrastromal corneal keraring segments.

ACTIVE COMPARATOR

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

Other: corneal ring segments

toric phakic posterior IOL implantation and corneal collagen cross linking

ACTIVE COMPARATOR

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

Other: corneal ring segments

Interventions

corneal ring segmentsOTHER

ring hard segments inserted within corneal stroma using femtolaser

Also known as: toric phakic posterior IOL implantation/ corneal collagen cross linking
corneal collagen cross linking and intrastromal corneal keraring segments.toric phakic posterior IOL implantation and corneal collagen cross linking

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Keratoconus grade I to III according to the Amsler-Krumeich classification

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Maher Khalafallah

Minya, Egypt

RECRUITING

MeSH Terms

Conditions

Keratoconus

Interventions

Corneal Cross-Linking

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PhotochemotherapyCombined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Central Study Contacts

ahmed maher khalafallah

CONTACT

01119094426drahmedmaher1988@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2021

First Posted

September 24, 2021

Study Start

November 28, 2019

Primary Completion

November 15, 2021

Study Completion

November 22, 2021

Last Updated

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)