Endothelial Cell Loss After Penetrating Keratoplasty
Sponsor
Alexandria University (Other)
Overall Status
Completed
CT.gov ID
NCT04457063
Collaborator
(none)
8
1
1
23.5
0.3
Study Details
Study Description
Brief Summary
This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
Penetrating keratoplasty (PKP) is considered a safe and effective procedure.This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty.
Study Design
Study Type:
Interventional
Actual Enrollment
:
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refractionA prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Endothelial Cell Loss Following Toric ICL Implantation for Correction of Myopia and Astigmatism After Penetrating Keratoplasty
Actual Study Start Date
:
Jul 1, 2018
Actual Primary Completion Date
:
Jun 1, 2020
Actual Study Completion Date
:
Jun 15, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: penetrating keratoplasty A prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction |
Procedure: PKP
The horizontal axis was marked with a pointed marker at the slit lamp immediately before surgery.
TICL loading into the STAAR injector cartridge
Temporal clear corneal 3 mm incision & 2-side ports then viscoelastic injection into the AC
Implantation of the TICL using the injector, then rotation according to the implantation diagram guided with Mendez protractor, and lastly placement of the haptics under the iris.
Pupil constriction with A.Ch.
Washing the viscoelastic &Wound hydration.
Topical antibiotic steroids (Vigamox and Tobradex) 4 times /day for 3weeks
|
Outcome Measures
Primary Outcome Measures
- Refraction [1 year]
Refractive measured by Diopter
- Visual acuity [1 year]
The decimal snellens
- Intra-ocular pressure [1 year]
mg
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction
Exclusion Criteria:
- Less than 18 and unable to give informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alexandria Faculty of Medicine | Alexandria | Egypt |
Sponsors and Collaborators
- Alexandria University
Investigators
- Principal Investigator: Ehab Mossallam, PhD, Alexandria Faculty of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Alexandria University
ClinicalTrials.gov Identifier:
NCT04457063
Other Study ID Numbers:
- 0304624
First Posted:
Jul 7, 2020
Last Update Posted:
Jul 7, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: