Bullous Pseudophakic KeratopathyDESPEKNCT06818747
Effectiveness of PKP vs DSAEK in Terms of 2-year Postoperative Visual Acuity in Advanced BPK
A study testing Best corrected monocular visual acuity in people with Bullous Pseudophakic Keratopathy and Penetrating Keratoplasty, run by Centre Hospitalier Régional Metz-Thionville at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Bullous Pseudophakic Keratopathy, Penetrating Keratoplasty
- What is being tested?
- Best corrected monocular visual acuity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 11 sitesFrance
- Study dates
- 21 May 2025to 21 Aug 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient:
- 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.
- Has provided free and informed written consent.
- Is affiliated to a social security scheme.
- Can be followed-up by the same investigating team during the study period.
Who cannot join
- The patient:
- 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.
- Is deprived of freedom, or under a legal protective measure.
- Is included in another clinical study.
- Has a severe general condition that might lead to premature discontinuation of the trial before the end of treatment period.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mélanie JUNKE contact
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
CHU Besançon - Hôpital Jean Minjoz
Besançon, 25030
Anne Sophie GAUTHIER
- Recruiting
CHU Bordeaux - Hopital Pellegrin
Bordeaux, 33076
David TOUBOUL, MD
- Recruiting
CHU Brest - Hopital Morvan
Brest, 29609
Béatrice COCHENER, MD
- Recruiting
CHR Metz-Thionville Hopital de Mercy
Metz, 57085
Arpiné EL NAR, projet-recherche-clinique@chr-metz-thionville.fr
Mélanie JUNKE, projet-recherche-clinique@chr-metz-thionville.fr
- Not yet recruiting
CHU Nantes - Hôpital Hotel-Dieu
Nantes, 44000
Bertrand VABRES, MD
- Not yet recruiting
APHP - Hopital Cochin
Paris, 75014
Jean-Louis BOURGES, MD
- Not yet recruiting
Chno Xv Xx
Paris, 75571
Pr. Vincent BORDERIE, MD
- Recruiting
CHU Saint-Etienne - Hôpital Nord
Saint-Etienne, 42055
Gilles THURET, MD
- Recruiting
CHRU Strasbourg - Nouvel Hôpital Civil
Strasbourg, 67091
Tristan BOURCIER, MD
- Recruiting
CHU Toulouse - Hopital Purpan
Toulouse, 31059
Pierre FOURNIE
- Recruiting
CHRU Tours
Tours, 37044
Marie PISELLA
Pr. Pierre-Jean PISELLA, MD
About this study
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
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.
Read the 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.
- Being tested
- Best corrected monocular visual acuity
- Keywords
- Best corrected monocular visual acuity, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best corrected monocular visual acuityProcedure or surgery
Assessed with the Monoyer scale and expressed in logMAR at 24 months after corneal transplantation
| Study group | Role | What they receive |
|---|---|---|
| DSAEK | Active comparator | DSAEK (Descemet Stripping Automated Endothelial Keratoplasty) involves replacing the patient's diseased endothelium and overlying Descemet membrane with a corneal graft composed of endothelium, Descemet membrane, and a thin layer of overlying stroma. Receives: Procedure: Best corrected monocular visual acuity |
| PKP | Active comparator | PKP (Penetrating Keratoplasty) involves removing a full-thickness central corneal disc from the diseased cornea and replacing it with an equivalent corneal disc from a deceased human donor. Receives: Procedure: Best corrected monocular visual acuity |
What is being measured
The primary outcome is the main question the study is designed to answer.
DSAEK and PKP comparison in terms of visual acuity
Best corrected monocular visual acuity (assessed with the Monoyer scale and expressed in logMAR)
Measured: At 24 postoperative months
Secondary outcomes (15)
Visual acuity
Change relative to preoperative baseline in best corrected monocular visual acuity (assessed with the Monoyer scale and expressed in logMAR)
Measured: 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).
Measured: 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
Measured: up to 24 postoperative months
Frequency of cases who require a regraft
Number of new transplant needed within 24 months
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: within 24 postoperative months
Corneal endothelial cell density
Endothelial cell density (cells/mm2)
Measured: at 6, 12, and 24 postoperative months.
Required optical correction
Required optical correction (diopter)
Measured: 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
Measured: with the 24 postoperative months
Change in central corneal thickness
Central corneal thickness (µm)
Measured: at 6, 12 and 24 months relative to preoperative baseline
Graft thickness
(µm)
Measured: 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
Measured: 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
Measured: within 24 postoperative months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start21 May 2025
- Primary completion21 May 2027 (estimated)
- Study completion21 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous Pseudophakic KeratopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc PERONE, MD, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818747
- Sponsor's protocol ID
- 2024-03-CHRMT
- Acronym
- DESPEK
- Status last verified
- Jun 2026
- First submitted
- 24 Dec 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No