Trials / Completed
CompletedNCT03321916
MacTel Laser Study
Controlled Pilot Study for Safety and Efficacy of Subthreshold Photothermal Therapy for Patients With Macular Telangiectasia (MacTel) Type 2
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- The Lowy Medical Research Institute Limited · Academic / Other
- Sex
- All
- Age
- 21 Years – 79 Years
- Healthy volunteers
- Not accepted
Summary
This is a two armed Single Masked Pilot Study enrolling participants with Macular Telangiectasia Type 2 who will be randomized to undergo either a subthreshold photothermal treatment or a sham procedure to one eye. The participants will be followed for one year with visits at 1 month, 3 months, 6 months and 12 months post-treatment (laser or sham). Due to the small number of participants enrolled in this study the data will be analyzed by descriptive statistics and exploratory figures. Summary statistics will be produced for study and fellow eyes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 577-nm PASCAL laser | The Topcon/Endpoint Management System™ is a cleared medical device commonly used in the treatment of ocular disorders. |
Timeline
- Start date
- 2018-02-08
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2017-10-26
- Last updated
- 2023-03-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03321916. Inclusion in this directory is not an endorsement.