Interval Intraocular Pressure in Intravitreal Injection Study

Status Completed

Clinical Trial Summary

This is a prospective study of IOP in Intravitreal injections to evaluate: 1. IOP effect of intravitreal injection 2. IOP response to prophylactic beta blocker or Prostaglandin vs control (Hypromellose) over multiple time periods 3. IOP response in correlation to number of injections, IOL, type of anti VEGF, co morbidities

Clinical Trial Description

Study design: A prospective study Sample size: 60 patients (180 readings) Recruitment: Patients will be recruited at the intravitreal injection clinic in Grantham Hospital. Randomization: Group 1: control (hypromellose), then Timolol, then Travatan Group 2: Timolol, then Travatan, Hypromellose Group 3: Travatan, then Hypromellose, Timolol There are three groups of different treatments. Patients recruited will undergone all three groups of treatments. During the first injection visit, patients will be randomized (by envelope method upon recruitment) to start with one of the three groups by envelope method. Treatment given to each group according to randomization in the first visit, then rotated to second and third group at two subsequent injections accordingly. Injection doctors masked to treatments given. Study visits: 1. Injection visit - Record the anti-VFGF injection to be given - Macula disease involved - Record no. of previous injections - Prophylactic eye drops will be given according to treatment group 1 hour prior injection - IOP immediately before injection (without speculum while sitting on table) - IOP immediately after injection (without speculum while sitting on table) - IOP 30 minutes after injection via iCare - Slitlamp examination, document inflammation or complications if any 2. Day 1 follow-up visit - IOP via iCare (sitting) - Slitlamp examination, document inflammation or complications if any 3. Week 1 follow-up visit - IOP via iCare (sitting) - Slitlamp examination, document inflammation or complications if any Visit a, b and c will be repeated for 2nd and 3rd injections. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04868175
Study type	Interventional
Source	The University of Hong Kong
Contact
Status	Completed
Phase	N/A
Start date	October 1, 2019
Completion date	April 1, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Interval Intraocular Pressure in Intravitreal Injection Study — IIII

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms