Clinical trial NCT06818747: Effectiveness of PKP vs DSAEK in Terms of 2-year Postoperative Visual Acuity in Advanced BPK
Official title: Comparative Effectiveness of PKP and DSAEK in Terms of 2-year Postoperative Visual Acuity in Advanced Bullous Pseudophakic Keratopathy: a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bullous Pseudophakic Keratopathy
Penetrating Keratoplasty
Keywords: Best corrected monocular visual acuity
Quality of life
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 334
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* The patient:

  1. Is ≥ 50 years old.
  2. 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.
  3. Is indicated for a corneal transplant.
  4. Is pseudophakic.
  5. Has provided free and informed written consent.
  6. Is affiliated to a social security scheme.
  7. Can be followed-up by the same investigating team during the study period.

Exclusion Criteria:

* The patient:

  1. Has a history of corneal transplant on either eye (i.e. the study surgery will be the first corneal transplant for the patient).
  2. Has an anterior chamber lens implant or is aphakic.
  3. 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.
  4. Has a contraindication to general anesthesia.
  5. Is deprived of freedom, or under a legal protective measure.
  6. Is included in another clinical study.
  7. Has a severe general condition that might lead to premature discontinuation of the trial before the end of treatment period.

Primary outcomes:
measure: DSAEK and PKP comparison in terms of visual acuity
timeFrame: At 24 postoperative months
Secondary outcomes:
measure: Visual acuity
timeFrame: at 6, 12, and 24 postoperative months (repeated measures model)
measure: Time taken to achieve a postoperative best corrected visual acuity of at least 4/10 (0.4 logMAR).
timeFrame: up to 24 postoperative months
measure: Percentage of patients achieving at least 4/10 (0.4 logMAR)
timeFrame: up to 24 postoperative months
measure: Frequency of cases who require a regraft
timeFrame: up to 24 postoperative months
measure: Change in quality of life at 12 and 24 months relative to preoperative baseline
timeFrame: 1 to 6 months before surgery and at 12 and 24 postoperative months
measure: Patient satisfaction
timeFrame: at 1, 6, 12, and 24 postoperative months relative to preoperative baseline.
measure: Pain level
timeFrame: at 1, 6, 12, and 24 postoperative months relative to preoperative baseline
measure: Complication number and types
timeFrame: within 24 postoperative months
measure: Corneal endothelial cell density
timeFrame: at 6, 12, and 24 postoperative months.
measure: Required optical correction
timeFrame: at 6, 12 and 24 postoperative months
measure: Emerging adverse events and serious adverse events
timeFrame: with the 24 postoperative months
measure: Change in central corneal thickness
timeFrame: at 6, 12 and 24 months relative to preoperative baseline
measure: Graft thickness
timeFrame: at 6, 12, and 24 months in DSAEK arm relative to baseline
measure: Scar dehiscence and major astigmatism in PKP arm, and graft detachment in DSAEK arm.
timeFrame: Within 24 postoperative months
measure: Suture removal and corneal contact lens equipment in PKP arm
timeFrame: within 24 postoperative months
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: CHU Bordeaux - Hopital Pellegrin
city: Brest
country: France
facility: CHU Brest - Hopital Morvan
city: Metz
country: France
facility: CHR Metz-Thionville Hopital de Mercy
city: Nantes
country: France
facility: CHU Nantes - Hôpital Hotel-Dieu
city: Paris
country: France
facility: APHP - Hopital Cochin
city: Paris
country: France
facility: Chno Xv Xx
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne - Hôpital Nord
city: Strasbourg
country: France
facility: CHRU Strasbourg - Nouvel Hôpital Civil
city: Toulouse
country: France
facility: CHU Toulouse - Hopital Purpan
city: Tours
country: France
facility: CHRU Tours
Study officials:
affiliation: CHR Metz Thionville Hopital de Mercy
name: Jean-Marc PERONE, MD
role: PRINCIPAL_INVESTIGATOR
References: