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.
Bullous pseudophakic keratopathy (PBK) is the development of irreversible corneal edema after cataract surgery. Since approximately 20 million people worldwide undergo cataract surgery annually, and PBK can occur in 1-2% of cataract operations, PBK remains a major indication for corneal transplantation. Indeed, it accounts for a quarter of the 5,000 corneal transplant operations that are conducted in France each year. Penetrating keratoplasty (PKP) involves transplanting a full-thickness corneal button. It was the only corneal transplant technique available for PBK until 2004-2006, when two posterior lamellar corneal transplantation methods were invented and refined, namely, Descemet stripping automated keratoplasty (DSAEK) and Descemet membrane endothelial keratoplasty (DMEK). Both have transformed the management of PBK and are often preferred over PKP because of faster visual improvement and fewer complications, including astigmatism and graft rejection. This is particularly true for cases where preoperative visual acuity is better than 2/10 (0.7 logMAR). However, PKP is still indicated when visual acuity is below the ability to see hand movements (2 logMAR): in such cases, the severe stromal damage requires full-thickness transplantation. However, for PBK cases with intermediate visual acuity (i.e. between 0.7 and 2 logMAR), there is doubt about the best therapeutic solution. The relatively severe corneal damage in these cases is a contraindication for DMEK, which is a much more technically challenging procedure than DSAEK. Thus, the surgeon must choose either DSAEK or PKP. DSAEK is suitable for older people who mainly complain of eye pain: it is a simple and painless procedure that leads to satisfactory outcomes in 75% of cases. However, in the remaining 25% of patients, ocular pain may persist and/or the recovery of visual acuity is too limited and the patient is dissatisfied. In such cases, the patient is indicated for regraft with PKP. Given the poor visual outcomes of DSAEK for a substantial minority of patients with preoperative visual acuity between 0.7 and 2 logMAR, the present study asks whether PKP should be the primary choice for such patients. To improve decision-making for PBK, the study also asks whether it is possible to define preoperative visual acuity and/or central corneal thickness (CCT) thresholds that signal a high risk of regraft after primary DSAEK and therefore indicate a need for primary PKP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
334
Assessed with the Monoyer scale and expressed in logMAR at 24 months after corneal transplantation
CHU Besançon - Hôpital Jean Minjoz
Besançon, France
NOT_YET_RECRUITINGCHU Bordeaux - Hopital Pellegrin
Bordeaux, France
NOT_YET_RECRUITINGCHU Brest - Hopital Morvan
Brest, France
NOT_YET_RECRUITINGCHR Metz-Thionville Hopital de Mercy
Metz, France
RECRUITINGCHU Nantes - Hôpital Hotel-Dieu
Nantes, France
NOT_YET_RECRUITINGAPHP - Hopital Cochin
Paris, France
NOT_YET_RECRUITINGChno Xv Xx
Paris, France
NOT_YET_RECRUITINGCHU Saint-Etienne - Hôpital Nord
Saint-Etienne, France
NOT_YET_RECRUITINGCHRU Strasbourg - Nouvel Hôpital Civil
Strasbourg, France
NOT_YET_RECRUITINGCHU Toulouse - Hopital Purpan
Toulouse, France
NOT_YET_RECRUITING...and 1 more locations
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 months
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)
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 months
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 months
Frequency of cases who require a regraft
Number of new transplant needed within 24 months
Time frame: up to 24 postoperative months
Change in quality of life at 12 and 24 months relative to preoperative baseline
as determined with the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25); the whole cohort and unilateral and bilateral PBK cases will be assessed separately. NEI VFQ-25 questionnaire measures the dimensions of self-reported vision-targeted health status that are most important for persons who have chronic eye diseases. The Visual Function Questionnaire (VFQ-25) consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points (100 is the best score), respectively.
Time frame: 1 to 6 months before surgery and at 12 and 24 postoperative months
Patient satisfaction
Numeric rating scale of patient satisfaction (scored from 0 to 10)
Time frame: at 1, 6, 12, and 24 postoperative months relative to preoperative baseline.
Pain level
Numeric rating scale for measuring pain of one (No pain) to 10 (Worst pain)
Time frame: at 1, 6, 12, and 24 postoperative months relative to preoperative baseline
Complication number and types
graft rejection, infection, cystoid macular edema, atrophic macular degeneration, epiretinal membrane, macular hole, ocular hypertonia, and whether the patient develops a postoperative herpetic attack or a flare of preexisting but previously undiagnosed herpes.
Time frame: within 24 postoperative months
Corneal endothelial cell density
Endothelial cell density (cells/mm2)
Time frame: at 6, 12, and 24 postoperative months.
Required optical correction
Required optical correction (diopter)
Time frame: at 6, 12 and 24 postoperative months
Emerging adverse events and serious adverse events
Nature and number of emerging adverse events and serious adverse events
Time frame: with the 24 postoperative months
Change in central corneal thickness
Central corneal thickness (µm)
Time frame: at 6, 12 and 24 months relative to preoperative baseline
Graft thickness
(µm)
Time frame: at 6, 12, and 24 months in DSAEK arm relative to baseline
Scar dehiscence and major astigmatism in PKP arm, and graft detachment in DSAEK arm.
The occurrence of scar dehiscence and major astigmatism in PKP arm, and graft detachment in DSAEK arm
Time frame: Within 24 postoperative months
Suture removal and corneal contact lens equipment in PKP arm
Number of suture removal and corneal contact lens equipment in PKP arm
Time frame: within 24 postoperative months
Mélanie JUNKE
CONTACT
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