Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT01657500
Eligibility Criteria:
Inclusion Criteria:
1. Subjects undergoing EK for FECD only.
2. Age range of 30-85 years with minimum life expectancy of at least 1 year
3. Willingness to return to study site at 1 month, 3 months, and 6 months to complete study procedures
4. Permissible EK procedures with preoperative diagnoses
* Pseudophakic FECD with posterior capsule supported or suture-fixated posterior chamber intraocular lens (IOL)
* Phakic FECD
* EK, phacoemulsification with posterior chamber IOL for phakic FECD with cataract
5. Stromal vascularization is acceptable
6. Controlled glaucoma on medication and/or previous trabeculectomy and laser trabeculoplasty is acceptable
Exclusion Criteria:
1\. Since EK is suitable only for corneal conditions with endothelial dysfunction, all corneal conditions not associated with endothelial failure that are managed with PKP only are excluded (e.g. keratoconus, stromal dystrophies, traumatic corneal scars).
* Other exclusions include:
* Other primary endothelial dysfunction conditions including pseudophakic bullous keratopathy not due to FECD, posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy
* Pseudophakic FECD with open loop anterior chamber IOL
* Previous failed keratoplasty, either EK or PKP
* Central subepithelial or stromal scarring detected preoperatively that could impact graft clarity assessment
* Anterior or peripheral anterior synechiae
* Uncontrolled glaucoma \> 25 Hg with or without prior filtering surgery or shunt placement.
* Controlled glaucoma with tube shunt placement.
* Uncontrolled Uveitis - Fellow eye visual acuity \< 20/200
* Fellow eye already included in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
85 Years
Study:
NCT01657500
Study Brief:
Protocol Section:
NCT01657500