Clinical trials are the experiments that involve the participation of human volunteers to find out whether a new treatment is safe, effective and superiority of the treatment. In Ophthalmology, clinical trials are mainly being conducted in the following therapeutic conditions:
- Astigmatism
- Cataracts
- Conjunctivitis, Bacterial
- Diabetic Macular Edema
- Diabetic Retinopathy
- Eye Disorders/Infections
- Glaucoma
- Macular Degeneration
- Macular Edema
- Ocular Hypertension
- Posterior Uveitis
- Retinitis Pigmentosa
- Sjogren’s Syndrome
- Uveitis
- Vitreous Hemorrhage
Ophthalmologists and Optometrists act as principal investigators in conducting clinical trials in eye diseases. Most of the ophthalmology clinical trials are randomized trials and sometimes include placebo in the control arm. A placebo is a harmless substance or a dummy dosage form that resembles the real treatment but has no effect on the eye disease or disorder. In surgery or medical device trials, subjects in the control arm would receive sham treatment which has no effect on eye disease or disorder like a placebo.
In recent years, a surge of interest has been seen in clinical research in the field of Ophthalmology, especially in Glaucoma surgery and device trials. Glaucoma is a controllable, but currently incurable disorder, which has the potential to impair health. Patients require ongoing treatment to prevent visual loss or other problems that result in a decrease in health. Even with maximal medicinal and surgical intervention, some patients will still lose vision either due to the disease or the complications of treatment, or both. Patients may also experience a multitude of ocular, systemic, and psychological complications of glaucoma, even when vision is preserved and the intraocular pressure (IOP) controlled.
While traditionally surgical trials have suffered from weaknesses such as case selection bias and variability in surgical technique, arguably the greatest weakness facing surgical trials in future will be the lack of a clear evidence base for many of our presumed thresholds for success. Accepting the difficulties and limitations involved in visual field reporting in surgical trials, large long-term studies of visual field progression are essential to test the conventional wisdom that the setting of certain ‘targets is actually beneficial to the patient with glaucoma.
Currently there are no clear guidelines on the conduct of glaucoma surgical clinical trials. World Glaucoma Association (WGA) took the initiative to form a steering committee, Methodology Sub-Committee (MSC) to develop guidelines for clinical studies in glaucoma surgery.