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11 February 2012
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| [ Print-friendly version ] |
| Phacoemulsification and changes in outflow facility |
| ISRCTN | ISRCTN04247738 |
| ClinicalTrials.gov identifier | |
| Public title | Phacoemulsification and changes in outflow facility |
| Scientific title | Phacoemulsification and changes in outflow facility in eyes with and without glaucoma |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis |
Changes of outflow facility after phacoemulsification in eyes with and without primary open angle glaucoma.
Further reading: 1. http://www.ncbi.nlm.nih.gov/pubmed/9261307 2. http://www.ncbi.nlm.nih.gov/pubmed/16488940 3. http://www.ncbi.nlm.nih.gov/pubmed/10966950 4. http://www.ncbi.nlm.nih.gov/pubmed/18452763 5. http://www.ncbi.nlm.nih.gov/pubmed/3579706 6. http://www.ncbi.nlm.nih.gov/pubmed/12714632 7. Moorfields manual of ophthalmology, 2008 Timothy Jackson, Mosby publications |
| Lay summary | |
| Ethics approval | St. Thomas' Hospital Research Ethics Committee (REC) approved on the 16th November 2009 (ref: 09/H0802/103 |
| Study design | Comparative clinical study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Glaucoma; outflow facility; phacoemulsification |
| Participants - inclusion criteria |
1. Aged greater than 21 years
2. Lens opacity deemed enough to be causing reduced vision 3. Diagnosis of primary open angle glaucoma (POAG) (Group 1) or no glaucoma (Group 2). POAG defined as glaucomatous optic neuropathy together with an intraocular pressure (IOP) greater than 21 mmHg on at least one occasion, visual field defects (using the 24-2 test pattern on a Humphrey Field Analyser) and a gonioscopic angle width of 3 or 4 and normal in appearance. 4. Patient's willingness to participate in the study and ability to give informed consent |
| Participants - exclusion criteria |
1. Previous intraocular surgery
2. Previous ocular trauma that can cause damage to the drainage angle (e.g. angle recession) 3. International normalised ratio (INR) greater than 3.0 on the day of surgery (for the patients on warfarin) 4. Anterior segment neovascularisation 5. Chronic use of systemic or topical steroid 6. Any other concurrent ocular disease e.g. uveitis, diabetic retinopathy, corneal diseae, etc. |
| Anticipated start date | 18/01/2010 |
| Anticipated end date | 18/08/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 20 patients in each groups |
| Interventions |
1. Visual acuity: using Snellen chart
2. Slit-lamp examination: including examination of the cornea for development of any signs of stromal oedema, gonioscopy using Zeiss or Goldmann gonioscopy lens in dimmed light (to determine angle grade). Angle grading will be according to the Shaffer’s system. Prior to instillation of fluorescein or dilating pupil, aqueous flare and cells will be graded using a slit lamp beam with the height of 3 mm and width of 1 mm directed across the pupil. Anterior chamber cells grading Grade 0 = no cells Grade 1 = 1 - 4 cells Grade 2 = 5 - 19 cells Grade 3 = greater than 20 cells Grade 4 = presence of fibrin Anterior chamber flare grading Grade 0 = none Grade 1 = visible flare Grade 2 = iris details obscured 3. Goldmann applanation tonometry: A topical anaesthetic and fluorescein drop will be used. The study eye’s IOP will be measured 3 times and the average will be recorded as the IOP. 4. Anterior chamber depth measurement. This non-contact measurement is done by using an ultrasound machine (IOL master, Carl Zeiss). This is a standard measurement needed for all patients prior to cataract surgery to measure their axial length and corneal power in order to calculate the power of replacement intraocular lens needed. 5. Outflow facility: The facility of outflow will be measured from the rate of decay of intraocular pressure in the supine position during application of a recording Schiötz tonometer over 4 minutes time. The "R" values of the curve at every 30 second time point will be manually entered into the McLaren tonography computer based program. The program fits a second degree polynomial by least squares to the nine data points and determines the best fit values for time 0 and time 4 minute by extrapolation. These initial and final values of the tonometer scale reading will be used to look up the value for the facility of outflow using 1955 scale approved by the Committee on Standardization of Tonometer. |
| Primary outcome measure(s) | Outflow facility |
| Secondary outcome measure(s) |
1. Anterior chamber depth
2. Intraocular pressure 3. Intra- or post-operative complications 4. Development of glaucoma |
| Sources of funding | EyeHope (UK) |
| Trial website | |
| Publications | |
| Contact name | Mr Kin Sheng Lim |
| Address |
St. Thomas' Hospital
Westminster Bridge Road |
| City/town | London |
| Zip/Postcode | SE1 7EH |
| Country | United Kingdom |
| Tel | +44 (0)20 7188 2289 |
| Fax | +44 (0)20 7188 9193 |
| shenglim@gmail.com | |
| Sponsor | Guy's and St. Thomas' NHS Foundation Trust (UK) |
| Address |
3rd Floor Conybeare House
Guy's Hospital St. Thomas' Street |
| City/town | London |
| Zip/Postcode | SE1 9RT |
| Country | United Kingdom |
| Tel | +44 (0)20 7188 5731 |
| karen.ignatian@gstt.nhs.uk | |
| Sponsor website: | http://www.guysandstthomas.nhs.uk/ |
| Date applied | 27/11/2009 |
| Last edited | 22/12/2009 |
| Date ISRCTN assigned | 22/12/2009 |
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| © 2012 ISRCTN unless otherwise stated. | |
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