ong-term follow-up and cross-over of treatment with high-density micropulse laser and half-dose photodynamic therapy in participants of the PLACE trial for chronic central serous chorioretinopathy.
- Conditions
- Chronic central serous chorioretinopathy10047060
- Registration Number
- NL-OMON40728
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 92
Only participants of the PLACE trial can be enrolled for this study.
In the Cross-over study, the following patients will be included:
- Subjects with persistent SRF on OCT at the final follow-up visit of the PLACE trial (7-8 months after Treatment Visit 1 PLACE trial) after either two PDT treatments in or two HSML treatments,
- Subjects with recurrence of SRF on OCT at the final follow-up visit of the PLACE trial after one PDT or one HSML treatment, will be included in the cross-over study.
Of note, for SRF on OCT does not have to involve the fovea for patients to be included in the cross-over study.
In the Long-term follow-up study, the following patients will be included:
- Subjects who do not show any SRF on OCT at final visit of the PLACE trial will be included.
Of note, patients who were not initially included in the long-term follow-up study, because of persistent SRF on OCT, were automatically included in the cross-over study.
For this study no exclusion criteria are applicable.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Absence of subretinal fluid on OCT at the long-term follow up visit, one year<br /><br>after baseline (final visit of the PLACE trial).<br /><br>- Absence of subretinal fluid on OCT at the evaluation visit 6-8 weeks after<br /><br>either first or second cross-over treatment as compared to either baseline<br /><br>(baseline = visit (last evaluation) at 7-8 months after first treatment in<br /><br>PLACE trial) or first re-treatment evaluation visit.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Mean change in ETDRS BCVA in the study eye from baseline to final follow-up<br /><br>visit (1 year after baseline).<br /><br>- Mean change in retinal sensitivity on microperimetry in the study eye from<br /><br>baseline to final follow-up visit (1 year after baseline).<br /><br>- Mean change in the NEI VFQ-25 questionnaire from baseline to final follow-up<br /><br>visit (1 year after baseline).<br /><br>- Number of recurrences of CSC within follow-up period.</p><br>