Patients with a diagnosis of irreversible pseudophakic chronic corneal edema who required penetrating corneal transplantation due to failure to improve with other medical treatments Eye Diseases
Conditions
Interventions
Participants in this study undergo either an unprotected or protected partial penetrating keratoplasty to treat chronic pseudophakic corneal edema.
Upon enrolment, patient data is gathered from medic
Sponsors
Universidad de Ciencias Médicas de la Habana
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients operated on for cataracts who developed chronic corneal edema resistant to medical treatment in an eye with some visual possibility 2. Written informed consent to participate in the research
Exclusion criteria
Exclusion criteria: 1. Refusal of the patient to undergo another surgical treatment or not having the possibility of vision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Visual acuity assessed using the Snellen E chart at baseline (preoperative), immediately postoperative, and at the follow-up visits scheduled weekly for the first 2 months, then every 2 months until completion of 1 year. 2. Endothelial cell count of the donor pre and post transplants is measured using specular microscopy (Topcon SP-3000P) at baseline (preoperative) and 1 year postoperative. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intraocular pressure is measured using a pneumatonometer preoperatively and postoperatively at each follow-up visit scheduled weekly for the first 2 months, then every 2 months until completion of 1 year. 2. Condition of the transplant, transparency, status of sutures, and tolerance to medication, evaluated by anterior segment biomicroscopy at each follow-up visit scheduled weekly for the first 2 months, then every 2 months until completion of 1 year. 3. Any intraoperative, immediate, and late complications are recorded and managed appropriately. The complications are evaluated at each follow-up visit scheduled weekly for the first 2 months, then every 2 months until completion of 1 year. 4. Postoperative medication tolerance evaluated by the patient's reported symptoms and by clinical evaluation during each follow-up visit scheduled weekly for the first 2 months, then every 2 months until the completion of 1 year. 5. Quality of life assessed using an NEI VFG-25 scale covering aspects like vision-related daily life activities, discomfort, and overall satisfaction with the treatment at baseline and at 1 year postoperative. | — |
Countries
Cuba
Outcome results
None listed