Effect of Panretinal Photocoagulation on Optic Nerve Head Topography

Diabetic Retinopathy Clinical Trial

— PRP  

Official title:

Effect of Panretinal Photocoagulation on Optic Nerve Head Topography and Nerve Fiber Layer Parameters

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00767884
• Other study ID #: 0413-08-EP
• Status: Terminated
• Start date: October 29, 2008
• Est. completion date: October 17, 2013

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the optic nerve head changes consequent to panretinal photocoagulation done for diabetic retinopathy.

Description:

Panretinal photocoagulation thermally ablates the retina to effect the regression of the neovascular process seen with diabetic retinopathy.2-6 Photocoagulative damage also damages the nerve fiber layer in the process. Since this should theoretically be associated with loss of nerve fibers it is expected to manifest as changes in optic nerve head cupping. There is no available literature to support this hypothesis. In fact the only available study done of the subject refuted the hypothesis.7 The study had a retrospective design and was done before any of the current technology to evaluate optic nerve head morphology was available.

Patients with concurrent glaucoma and diabetes often undergo panretinal photocoagulation as a part of their diabetes treatment. Optic disc cupping is a standard outcome measure for glaucoma diagnosis and progression. If PRP were to cause increased cupping, this can be a significant confounder in determining glaucoma progression based on optic nerve cupping. The findings of the study will help us determine as to how much cupping can be attributed to the PRP, if any at all.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: October 17, 2013
• Est. primary completion date: October 17, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Any patient with proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy otherwise undergoing panretinal photocoagulation for treatment.

Exclusion Criteria:

• Any patient with uncontrolled glaucoma (IOP above target on any occasion in the preceding 6 months) or other optic neuropathy that may confound the analysis of optic nerve head morphology.

• Patients with media opacities (significant cataract, corneal opacity, vitreous hemorrhage) precluding imaging of the optic nerve.

• No PRP done in the previous 6 months.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center Eye Clinic	Omaha	Nebraska
United States	UNMC Truhlsen Eye Institute	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in optic nerve head topography before and after panretinal photocoagulation	Compare changes in optic nerve head topography before and after panretinal photocoagulation (PRP)	3 years