Patient outcomes and glaucoma treatment
Results reported from clinical trials do not always tell the full story of patients’ experience of their treatment
Patient reported outcomes are becoming increasingly recognised as an important parameter in gauging the overall effect of glaucoma treatment on patients’ quality of life, according to Stefano Gandolfi MD.
Results reported from clinical trials do not always tell the full story of patients’ experience of their treatment. For that reason, the FDA, in close collaboration with the American Glaucoma Society, has recently framed an initiative to include patient reported outcomes as endpoints in clinical trials, said Dr Stefano Gandolfi, MD, University Eye Clinic, Parma, Italy
“Patient reported outcomes actually came in the room through the main door and they are here to stay,” he added.
To illustrate how potentially misleading the usual parameters for the success of glaucoma treatment can be, Dr Gandolfi described the outcomes of two initially similar glaucoma patients who followed separate treatment paths.
The first patient was a 55-year-old man who presented with 20/20 visual acuity and mid-stage glaucoma and a clear lens. He underwent trabeculectomy and according to the types of results reported in large randomised trial, he had a seven-year complete success in terms of IOP control and 10 years without progression.
However, during that time the patient also developed bleb-induced dry eye which meant he could no longer engage in water sports. Furthermore, at seven years follow-up he developed a cataract, likely induced by the trabeculectomy, and the subsequent cataract procedure caused the bleb to fail.
Dry eye induced by the bleb also made him intolerant to eye drops. He was able to achieve an IOP of 18mmHg on a combined regimen following a 180-degree laser trabeculoplasty, but he also developed posterior capsule opacification, and subsequent YAG-laser capsulotomy induced a posterior vitreous detachment causing dysphotpsias, meaning he could no longer ride a bicycle.
The second patient in this example was also a 55-year-old man with mid-stage glaucoma and a clear lens and a visual acuity of 20/20, he underwent a non-penetrating canaloplasty procedure. In terms of IOP control he was partial success/failure, in that he required medication to keep the pressure at low levels. His condition also progressed slightly at five years,
On the other hand, he still maintained a visual acuity of 20/20 at the age of 64 with no change in his activities.
“Between these two scenarios I think the vast majority of folks would prefer to be in the second scenario rather than the first one,” Dr Gandolfi said.