| Condition or disease |
|---|
| Glaucoma |
| Study Type : | Observational |
| Actual Enrollment : | 40 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Comparative Effectiveness and Tolerance of Subliminal Subthreshold Transscleral Cyclophotocoagulation With a Duty Factor of 25 % Versus 31.3 % for Advanced Glaucoma |
| Actual Study Start Date : | October 12, 2018 |
| Actual Primary Completion Date : | January 1, 2019 |
| Actual Study Completion Date : | January 12, 2019 |
| Group/Cohort |
|---|
|
25% cycle ratio
Patients group treated with CPCTSI at a 25% cycle ratio
|
|
31.3% cycle ratio
Patients group treated with CPCTSI at a 31.3% cycle ratio
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
| France | |
| Groupe Hospitalier Paris Saint-Joseph | |
| Paris, France, 75014 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 22, 2019 | ||||
| First Posted Date | May 23, 2019 | ||||
| Last Update Posted Date | May 28, 2019 | ||||
| Actual Study Start Date | October 12, 2018 | ||||
| Actual Primary Completion Date | January 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Efficiency - Difference in success rates [ Time Frame: Year 1 ] Change in success rates between two groups of patients.
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| Original Primary Outcome Measures |
Efficiency - Difference in success rates [ Time Frame: Year 1 ] Difference in success rates between two groups of patients.
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| Change History | |||||
| Current Secondary Outcome Measures |
Tolerance - Differences in occurrence frequency of side effects [ Time Frame: Year 1 ] Changes in occurrence frequency of side effects between two groups of patients.
|
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| Original Secondary Outcome Measures |
Tolerance - Differences in occurrence frequency of side effects [ Time Frame: Year 1 ] Differences in occurrence frequency of side effects between two groups of patients.
|
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Comparative Effectiveness and Tolerance of Subliminal Subthreshold Transscleral Cyclophotocoagulation | ||||
| Official Title | Comparative Effectiveness and Tolerance of Subliminal Subthreshold Transscleral Cyclophotocoagulation With a Duty Factor of 25 % Versus 31.3 % for Advanced Glaucoma | ||||
| Brief Summary | Glaucoma, progressive optical neuropathy, is the leading cause of irreversible blindness in the world. Glaucoma treatment aims to lower intraocular pressure (IOP) by using medication, laser and surgery. Patients suffering from refractory and advanced glaucoma with impaired visual field who are not good candidates for surgery, cadenced subcleral transscleral cyclophotocoagulation (CPCTSI) is commonly used to reduce IOP. The CPCTSI consists in delivering short bursts of energy (in cycle) to the ciliary body, thus reducing production of aqueous humor. The energy gusts develop sequentially to a photocoagulating state in the pigmented epithelium. They are spaced by rest periods that allow surrounding tissue to cool down and remain below photocoagulative threshold, thus avoiding damage to surrounding tissue. Some studies have shown that the risk of complications increases with higher energies. Complications associated with CPCTSI include prolonged intraocular inflammation, pain, intraocular hemorrhage, hypotonia, phthysis, decreased vision and sympathetic ophthalmia. Severity of these complications depends on collateral damage inflicted on surrounding tissues: ciliary muscles, unpigmented epithelium and stroma of ciliary body. Currently, CPCTSI with a cycle ratio of 25% and 31.3% are used in surgical routine in ophthalmology. Cycle ratio is ratio between duration of gusts and total duration of cycle (gusts and rest periods). At St. Joseph's Hospital, both cycle ratios are used and the choice is operator dependent. However, using CPCTSI with a 25% cycle ratio could have fewer complications while maintaining similar efficacy. To our knowledge, there are no studies comparing these two cycle reports, although they are commonly used in practice. Our objective is to compare the CPCTSI with a cycle ratio of 25% and 31.3%. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with refractory and advanced glaucoma | ||||
| Condition | Glaucoma | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
40 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | January 12, 2019 | ||||
| Actual Primary Completion Date | January 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03961035 | ||||
| Other Study ID Numbers | CPCTSI | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Groupe Hospitalier Paris Saint Joseph | ||||
| Study Sponsor | Groupe Hospitalier Paris Saint Joseph | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Groupe Hospitalier Paris Saint Joseph | ||||
| Verification Date | May 2019 | ||||