Objective:
The primary objective of this post market clinical study is to confirm the safety and efficacy of selective laser trabeculoplasty in mild to moderate primary open angle glaucoma patients in Indian population with regard to control of intraocular pressure, change in glaucoma medication, need to receive further glaucoma treatment as well as complications and side effect associated with the procedure.
Clinical investigation design:
An interventional, open, prospective, post-market clinical investigation, in which eligible patients will be enrolled, treated with the VISULAS green with option SLT, and followed for a six-month period. The enrollment period is expected to be 6 months. Given the time for scheduling of treatment and the follow-up period of 6 months, the data collection is expected to have an overall duration of 14 months. Patients will be recruited from the Glaucoma department, screened for eligibility, and informed consent will be obtained from those who meet screening criteria and are interested in participating. The patient number will be assigned sequentially when the study eligibility criteria are met, and the informed consent has been signed. It is expected that at least 10 patients are being recruited per month. Eligible patients will be examined preoperatively to obtain their medical history and to establish the baseline ocular examination. Treatment will be performed on Day 0 using the VISULAS green with SLT for SLT treatment and a mirror goniolens to visualize the trabecular meshwork. The initial energy level is set according to the grade of angle pigmentation. Approximately one hundred non-overlapping lesions will be applied in a single session to 360° of the trabecular meshwork except for highly pigmented TM where number of lesions should be reduced to max 50. Perioperative medication will be given according to the clinics standard of care and documented accordingly. Consistent with the standard of care, study patients will follow a regimen of postoperative care. Patients continue to take their preoperative glaucoma medications (number and substances) until end of the clinical investigation. Only in case the patient cannot tolerate the pre-operative glaucoma medication after the treatment, the investigator will change the medication as necessary for the well-being of the patient. The change in glaucoma medication will be documented (incl. the reason) on the Medication Log. Systemic medications that are considered necessary for the patient’s welfare may be used. The follow-up visits after SLT will be done as per the schedule given below. The total duration of follow-up will be 6 months for each patient. Postoperatively intraocular pressure, visual field, glaucoma medication, general eye status, need of further glaucoma treatment as well as complications and side effect associated with the procedure if any will be noted. Measurements of intraocular pressure will be taken for each patient (at a similar period of the day at each study visit) in a sitting position with a Goldmann applanation tonometer.
Population:
A minimum of 30 patients (aim: 60 patients) of the clinic, who are eligible to the study inclusion / exclusion criteria and are willing and able to participate in the clinical investigation and will be able to complete clinical follow-up and evaluation. Approximately half of the patients shall be treatment-naïve and half patients with prior glaucoma medication (adjunctive).
Inclusion/exclusion criteria:
Inclusion criteria: 1. Patients aged equal to or more than 22 years 2. Patients with mild to moderate primary open angle glaucoma who are eligible to undergo SLT treatment in one or both eyes 3. IOP with or without medication ≥ 21 mmHg in the study eye 4. Patients willing to give informed consent 5. Patients are willing and able to return for follow-up examinations 6. In the opinion of the investigator, the patient will be compliant and have a high probability of completing the data collection and all required procedures
Exclusion Criteria: 1. Very advanced glaucoma in either eye 2. Congenital glaucoma 3. Angle closure glaucoma (both primary and secondary) 4. Corneal disease or pathology in a way that distortion of laser light in the treated eye can be expected or that precludes stabilization of the cornea by the contact glass, visibility of the trabecular meshwork or transmission of laser wavelength 5. Any known contraindication to SLT which include: - Angle closure glaucoma if trabecular meshwork is not visible - Neovascular glaucoma - Acute inflammatory glaucoma - Blood vessels in the Schlemm’s canal 6. Any kind of planned ocular surgeries during the next 3 months (for example, cataract surgery) in either eye 7. History of intraocular surgery/ALT/angle-based surgery 8. Enrollment in another drug or device study within the prior 3 months
Effectiveness endpoints:
The endpoint is the mean change in intraocular pressure (IOP) of the patient cohort compared to baseline at month 3 (primary analysis) and month 6 (secondary analysis) - Absolute value (mmHg, primary endpoint) - Relative value (%, secondary endpoint) Thus, the primary effectiveness endpoint is the mean absolute change from baseline to month 3 in IOP.
Additional Exploratory Endpoints:
The following exploratory endpoints will be determined additionally: • Percentage of patients with >=20% IOP reduction • Subgroup analysis of treatment-naïve patients and adjunctive therapy • Change in glaucoma medication (number, dosage) • Need to receive further glaucoma treatment within 6 months post SLT
Safety endpoints:
• Post-operative intraocular pressure (IOP): 1h, 1d • Rate of intraoperative Adverse Effects • Rate of Adverse Effects over the entire course of the study • Rate of Adverse Events and Severe Adverse Events over the entire course of the clinical investigation • Changes in BCVA Safety parameters will be analyzed by descriptive statistics
Study Duration:
Preoperative Evaluation - Day -180 to day 0 | Preoperative Evaluation | Day -180 to day 0 | | Operative Evaluation: | Day 0 (day of surgery) | | Postop Day 1: | Days 1 to 2 | | Postop Month 1: | Days 21 to 35 (Weeks 3 to 5) | | Postop Month 3: | Days 70 to 98 (Weeks 10 to 14) | | Postop Month 6: | Days 147 to 182 (Weeks 21 to 26) |
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