Effectiveness of PKP vs DSAEK in Terms of 2-year Postoperative Visual Acuity in Advanced BPK
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorCentre Hospitalier Régional Metz-Thionville
About this trial
This is an open-label multicenter randomised controlled clinical trial with 2 parallel arms with a 1:1 ratio. Patients meeting the eligibility criteria will be offered to participate in the study during an ophthalmology consultation. If they agree, they are randomised into one of the 2 arms, surgery is scheduled, and baseline visual acuity, quality of life, patient satisfaction, pain level, and central corneal thickness are recorded (inclusion visit). The following visits involve: the corneal transplant procedure (DSAEK or PKP depending on the randomisation) and follow-up visits at 1, 6, 12, and 24 months. At each visit, visual acuity, patient satisfaction, pain level and complications will be determined. At 6, 12, and 24 months, endothelial cell density, central corneal thickness and required optical correction will be measured. At 12 and 24 months, quality of life, will also be determined.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Is ≥ 50 years old.
Has advanced PBK, with a best corrected visual acuity that lies between being able to see a hand move (i.e. 2 logMAR, included) and 2/10 excluded (i.e. 0.7 logMAR, excluded) and a central corneal thickness that exceeds 600 μm.
Is indicated for a corneal transplant.
Is pseudophakic.
Disqualifiers
Has a history of corneal transplant on either eye (i.e. the study surgery will be the first corneal transplant for the patient).
Has an anterior chamber lens implant or is aphakic.
Has an ocular comorbidity that will impact visual acuity recovery: exudative or advanced atrophic AMD, advanced diabetic retinopathy (macular edema), advanced glaucoma (damage to the central visual field), important sequelae of central venous thrombosis of the retina or retinal detachment, previous amblyopia.
Has a contraindication to general anesthesia.
Trial design
Design model
Parallel
Treatments tested in this trial
Best corrected monocular visual acuity
Procedure/SurgeryAssessed with the Monoyer scale and expressed in logMAR at 24 months after corneal transplantation
Treatment groups
334 Participants
are divided into 2 treatment groupsGroup A: DSAEKActive comparator 1 intervention
Group B: PKPActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
DSAEK and PKP comparison in terms of visual acuity
Best corrected monocular visual acuity (assessed with the Monoyer scale and expressed in logMAR)
Time frame
At 24 postoperative monthsSecondary outcomes
1
Visual acuity
Change relative to preoperative baseline in best corrected monocular visual acuity (assessed with the Monoyer scale and expressed in logMAR)
Time frame
at 6, 12, and 24 postoperative months (repeated measures model)2
Time taken to achieve a postoperative best corrected visual acuity of at least 4/10 (0.4 logMAR).
Number of months between surgery and the date of achieving a postoperative best corrected visual acuity of 0.4 logMAR or censor (last assessment by the investigator).
Time frame
up to 24 postoperative months3
Percentage of patients achieving at least 4/10 (0.4 logMAR)
Number and percentage of patients achieving at least 0.4 logMAR
Time frame
up to 24 postoperative months4
Frequency of cases who require a regraft
Number of new transplant needed within 24 months
Time frame
up to 24 postoperative monthsSponsors and contacts
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Source ClinicalTrials.gov