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Aqueous Release to Treat IOP Spikes Post-cataract Surgery

Primary Purpose

Post-Op Complication, Raised Ocular Pressure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aqueous release of the wound
Sponsored by
Bedford Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Op Complication

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient whose post-operative IOP was regarded to be too high for visual safety, or higher than 30mmHg, on the same day or within 1 week of the surgery

Exclusion Criteria:

  • Patients with IOP less than 30 mmHg or IOP deemed by clinician not too high to treat
  • Patients unable to cooperate
  • Patients who have undergone complicated cataract surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Aqueous release (Burping) of the wound

    Arm Description

    Following uneventful cataract surgery, wound "burping" will be performed in all eligible patients who gave their informed consent. The procedure will be offered whenever the intraocular pressure (IOP) is either higher than 30 mmHg or deemed inappropriate in view of the ocular condition (e.g. glaucoma). After 'burping' the wound, patients will have their IOP measured using Goldmann application tonometry (GAT) immediately and at 2 hours. The 'burping' procedure will be repeated until satisfactory pressure is achieved and care will be taken to avoid shallowing of the anterior chamber while fluid is released. We will assess for the presence of leaks from the wound with a Seidel test with fluorescein 5% once the IOP is satisfactory. To prevent any infection after each procedure, we will prescribe post-op drops including chloramphenicol 0.5% four times a day for 2 weeks or minimum of 3 days and these will continue as per routine. All other complications will be recorded at follow-up.

    Outcomes

    Primary Outcome Measures

    Efficacy of 'burping' the wound to reduce IOP (mmHg) post-cataract surgery when measured using Goldmann application tonometry (GAT)
    Reduction in IOP (mmHg) post-cataract surgery after the 'burping' procedure

    Secondary Outcome Measures

    Range of IOP decrease (mmHg)
    To observe and record the range of IOP decrease (mmHg) from individual 'burping' procedures
    Frequency of complications post-'burping' procedure
    Observing the frequency of complications, including but not limited to, severe pain, worsening of vision, or infection

    Full Information

    First Posted
    April 6, 2018
    Last Updated
    July 26, 2018
    Sponsor
    Bedford Hospital NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03500809
    Brief Title
    Aqueous Release to Treat IOP Spikes Post-cataract Surgery
    Official Title
    Efficacy and Safety of Aqueous Humour Release (Burping) Performed at the Slit-lamp to Treat Acute Intraocular Pressure (IOP) Spikes Post-cataract Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 12, 2018 (Anticipated)
    Primary Completion Date
    January 12, 2019 (Anticipated)
    Study Completion Date
    July 12, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bedford Hospital NHS Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Intraocular pressure (IOP) rise after cataract surgery is an important and common problem. Over 300,000 cataract operations are done per year in the United Kingdom alone. IOP rise can adversely affect vision and can be particularly detrimental in glaucoma patients with pre-existing visual field defects. The aim of this study is to evaluate the efficacy and safety of aqueous humor release (also known as burping of the wound), a procedure that has been used for decades to quickly reduce acute IOP spikes following cataract surgery. Currently there is no published evidence on a standard technique to perform wound burping. Similarly there is uncertainty around the amount and duration of the IOP decrease, and the type and frequency of complications eventually associated. This will be the first research project formally evaluating this procedure. This study will also help allay issues over fluid release in high IOPs and consequences of such dramatic IOP drop which concerns ophthalmologists who do not routinely use this technique.
    Detailed Description
    At present there is no de facto standard to manage acute intraocular pressure (IOP) rise following cataract surgery. Several drugs, both topical and systemic, have been tested for their ability to blunt the acute IOP spike, nevertheless none has proven to be superior and consistently effective. Oral acetazolamide has demonstrated to help controlling IOP spikes following cataract surgery in glaucomatous eyes. However there are still constraints in its widespread use, as it may be contraindicated in patients with poor renal function, sickle cell disease and sulpha drug allergy. As a result, many units including Moorfields Eye Hospital have used a technique called known as 'burping of the corneal wound' to release fluid from inside the anterior chamber of the eye. This makes logical sense as it reduces the pressure immediately and may remove some of the causes for raised IOP such as retained viscoelastic and inflammatory molecules from inside the eye. This technique has also been used to reduce IOP in patients already receiving pharmaceutical treatment. The technique has been used for decades, however, there is no published evidence of a proposed technique, range of IOP decrease or frequency of complications. Thus, most surgeons in most units are cautious of 'burping the wound' as it may induce infection or other complications compromising the surgical outcome due to the sudden reduced IOP reduction. Nevertheless a similar approach, needle penetrating the eye to release aqueous and reduce IOP, is becoming more popular as the first approach to treat an acute angle closure crisis, where the presenting IOP is often very high, i.e. a much more difficult and dangerous situation than post cataract surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-Op Complication, Raised Ocular Pressure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Aqueous release (Burping) of the wound
    Arm Type
    Experimental
    Arm Description
    Following uneventful cataract surgery, wound "burping" will be performed in all eligible patients who gave their informed consent. The procedure will be offered whenever the intraocular pressure (IOP) is either higher than 30 mmHg or deemed inappropriate in view of the ocular condition (e.g. glaucoma). After 'burping' the wound, patients will have their IOP measured using Goldmann application tonometry (GAT) immediately and at 2 hours. The 'burping' procedure will be repeated until satisfactory pressure is achieved and care will be taken to avoid shallowing of the anterior chamber while fluid is released. We will assess for the presence of leaks from the wound with a Seidel test with fluorescein 5% once the IOP is satisfactory. To prevent any infection after each procedure, we will prescribe post-op drops including chloramphenicol 0.5% four times a day for 2 weeks or minimum of 3 days and these will continue as per routine. All other complications will be recorded at follow-up.
    Intervention Type
    Procedure
    Intervention Name(s)
    Aqueous release of the wound
    Other Intervention Name(s)
    'Burping' procedure
    Intervention Description
    Anaesthetic drop (tetracaine 1%) followed by povidone iodine 5% drop is instilled. After 5 minutes, a sterile 30 gauge needle tip is pressed on the posterior lip of the one of the existing cuts (paracentesis or main wound) from cataract surgery to release the fluid and consequently the pressure. This will be performed under careful monitoring to avoid any undesirable shallowing of the anterior chamber of the eye.
    Primary Outcome Measure Information:
    Title
    Efficacy of 'burping' the wound to reduce IOP (mmHg) post-cataract surgery when measured using Goldmann application tonometry (GAT)
    Description
    Reduction in IOP (mmHg) post-cataract surgery after the 'burping' procedure
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Range of IOP decrease (mmHg)
    Description
    To observe and record the range of IOP decrease (mmHg) from individual 'burping' procedures
    Time Frame
    6 months
    Title
    Frequency of complications post-'burping' procedure
    Description
    Observing the frequency of complications, including but not limited to, severe pain, worsening of vision, or infection
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient whose post-operative IOP was regarded to be too high for visual safety, or higher than 30mmHg, on the same day or within 1 week of the surgery Exclusion Criteria: Patients with IOP less than 30 mmHg or IOP deemed by clinician not too high to treat Patients unable to cooperate Patients who have undergone complicated cataract surgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anant Sharma, MBBS, FRCOphth
    Phone
    01234355122
    Ext
    01234
    Email
    anant.sharma@bedfordhospital.nhs.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rynda Nitiahpapand, MBBS
    Phone
    01234355122
    Ext
    01234
    Email
    rynda.nitiahpapand@bedfordhospital.nhs.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anant Sharma, MBBS, FRCOphth
    Organizational Affiliation
    Bedford Hospital Moorfields Eye Unit
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25679413
    Citation
    Day AC, Donachie PH, Sparrow JM, Johnston RL; Royal College of Ophthalmologists' National Ophthalmology Database. The Royal College of Ophthalmologists' National Ophthalmology Database study of cataract surgery: report 1, visual outcomes and complications. Eye (Lond). 2015 Apr;29(4):552-60. doi: 10.1038/eye.2015.3. Epub 2015 Feb 13.
    Results Reference
    background
    PubMed Identifier
    21527959
    Citation
    Kim JY, Jo MW, Brauner SC, Ferrufino-Ponce Z, Ali R, Cremers SL, Henderson BA. Increased intraocular pressure on the first postoperative day following resident-performed cataract surgery. Eye (Lond). 2011 Jul;25(7):929-36. doi: 10.1038/eye.2011.93. Epub 2011 Apr 29.
    Results Reference
    background
    PubMed Identifier
    15002028
    Citation
    Tranos P, Bhar G, Little B. Postoperative intraocular pressure spikes: the need to treat. Eye (Lond). 2004 Jul;18(7):673-9. doi: 10.1038/sj.eye.6701319.
    Results Reference
    background
    PubMed Identifier
    20212196
    Citation
    Kass MA, Gordon MO, Gao F, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JK, Miller JP, Parrish RK, Wilson MR; Ocular Hypertension Treatment Study Group. Delaying treatment of ocular hypertension: the ocular hypertension treatment study. Arch Ophthalmol. 2010 Mar;128(3):276-87. doi: 10.1001/archophthalmol.2010.20.
    Results Reference
    background
    PubMed Identifier
    28110949
    Citation
    Hayashi K, Yoshida M, Manabe SI, Yoshimura K. Prophylactic Effect of Oral Acetazolamide against Intraocular Pressure Elevation after Cataract Surgery in Eyes with Glaucoma. Ophthalmology. 2017 May;124(5):701-708. doi: 10.1016/j.ophtha.2016.12.027. Epub 2017 Jan 19.
    Results Reference
    background
    PubMed Identifier
    26266045
    Citation
    Wang Q, Harasymowycz P. Short-Term Intraocular Pressure Elevations after Combined Phacoemulsification and Implantation of Two Trabecular Micro-Bypass Stents: Prednisolone versus Loteprednol. J Ophthalmol. 2015;2015:341450. doi: 10.1155/2015/341450. Epub 2015 Jul 21.
    Results Reference
    background
    PubMed Identifier
    25870663
    Citation
    Cioboata M, Anghelie A, Chiotan C, Liora R, Serban R, Cornacel C. Benefits of anterior chamber paracentesis in the management of glaucomatous emergencies. J Med Life. 2014;7 Spec No. 2(Spec Iss 2):5-6.
    Results Reference
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    Aqueous Release to Treat IOP Spikes Post-cataract Surgery

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