A pilot randomised masked study of ILM peeling with the new Grieshaber Sharkskin forceps as compared to the existing Grieshaber finesse forceps: the PRECISE study

Not Applicable

Completed

• Conditions: Macular holes; Eye Diseases

• Registration Number: ISRCTN70557873
• Lead Sponsor: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2023 Results article in https://doi.org/10.1007/s00417-022-05932-y (added 10/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-06
• Study Completion: 2020-11-17
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1. Primary idiopathic macular hole of any size and less than 12-month duration
2. Other previous treatments (gas, OCP) allowed
3. Full comprehension of study requirements at time of consent (at discretion of clinician)
4. Aged 50 years or older

Exclusion Criteria

1. ILM peeling not planned
2. MH secondary to other causes including trauma, previous retinal detachment
3. Previous vitrectomy surgery
4. Previous significant macular disease affecting visual acuity (mild early or intermediate AMD allowed)
5. Advanced glaucoma
6. Known vision affecting optic nerve disease
7. Diabetic retinopathy of more than R1 including previously treated PDR
8. Significant intraocular inflammation
9. Myopia > -6 dioptres or axial length > 26mm
10. Amblyopia of less than ~6/18
11. Conditions affecting ability to perform visual fields or imaging
12. Participation in any other clinical/interventional trial that may impact study findings

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recruitment and retention rate recorded as the number of eligible participants who consent to participate in the study over a four-month recruitment period and complete patient schedule in adherence to protocol

Secondary Outcome Measures

Name	Time	Method
1. Inner retinal changes measured by standard visual acuity assessments, eye imaging and recording of any adverse events post-surgery at 3 weeks, 3 month and 6-month time points<br>2. Surgeon perception of device performance during ILM procedure measured by the study questionnaire completed immediately after surgery