Aqueous Release to Treat IOP Spikes Post-cataract Surgery

NCT03500809 | Unknown DMC

• 1 other identifier: IRAS 240539
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post-Op Complication; Raised Ocular Pressure

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (2)

• Range of IOP decrease (mmHg)

  6 months

• Frequency of complications post-'burping' procedure

  6 months

Study Arms (1)

Aqueous release (Burping) of the wound

EXPERIMENTAL

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.

Procedure: Aqueous release of the wound

Interventions

Aqueous release of the wound PROCEDURE

1. 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. 2. This will be performed under careful monitoring to avoid any undesirable shallowing of the anterior chamber of the eye.

Also known as: 'Burping' procedure

Aqueous release (Burping) of the wound

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bedford Hospital NHS Trust: lead

Related Publications (7)

• 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.

  PMID: 25679413 BACKGROUND

• 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.

  PMID: 21527959 BACKGROUND

• 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.

  PMID: 15002028 BACKGROUND

• 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.

  PMID: 20212196 BACKGROUND

• 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.

  PMID: 28110949 BACKGROUND

• 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.

  PMID: 26266045 BACKGROUND

• 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.

  PMID: 25870663 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anant Sharma, MBBS, FRCOphth

  Bedford Hospital Moorfields Eye Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anant Sharma, MBBS, FRCOphth

CONTACT

01234355122; anant.sharma@bedfordhospital.nhs.uk

Rynda Nitiahpapand, MBBS

CONTACT

01234355122; rynda.nitiahpapand@bedfordhospital.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Ophthalmic Surgeon

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 18, 2018
• Study Start: August 12, 2018
• Primary Completion: January 12, 2019
• Study Completion: July 12, 2019
• Last Updated: July 27, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share