Effect of phacoemulsification on trabeculectomy function
| ISRCTN | ISRCTN91835217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91835217 |
| Secondary identifying numbers | BOPH-D-16-00308R2 |
- Submission date
- 30/05/2017
- Registration date
- 06/06/2017
- Last edited
- 26/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Cataracts occur when the inner lens of the eye clouds, causing vision problems. Glaucoma (high pressure inside the eye) can also cause vision problems. Cataracts can occur alongside glaucoma but also may cause glaucoma, be a result of glaucoma (high pressure inside the eye). For those who have glaucoma and cataracts, there are a number of options on how to treat them. Trabeculectomy is usually done to help lower the internal pressure of the eye by making a surgical incision through a small thin trap door in the eye to drain the fluid. However, this may have an impact on cataract surgery and requires certain management of treatment and medication. One of the main treatments for cataracts is called phacoemulsification, which is a surgical procedure that using a device to break up the cloud lens, and then inserts an intraocular lens (IOL) (an artificial lens) using an incision. Incisions can be made in different locations. The aim of this study is to compare two different corneal (the front clear layer of the eye) incisions of uneventful phacoemulsification and IOL on eyes that have undergone previous successful surgery for glaucoma.
Who can participate?
Adults aged 18 or older who previously had a success trabeculectomy for glaucoma who need cataract surgery
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group undergo phacoemulsification with a temporal (near the front) corneal incision. Those in the second group undergo phacoemulsification with a superior corneal incision (done under the eye lid). Participants in each group are compared for their intraocular pressure changes (pressure in the eye), any blebs (part of the eye ballooning and protruding from the top of the eyeball) and any needed medication for glaucoma.
What are the possible benefits and risks of participating?
Participants may benefit from improvements in vision. There are small risks associated with phacoemulsification such as infections, retinal detachment, flashing, double vision or swelling in the eye.
Where is the study run from?
Sohag University (Egypt)
When is the study starting and how long is it expected to run for?
October 2014 to January 2016.
Who is funding the study?
Investigator initiated and funded (Egypt)
Who is the main contact?
Dr Mohamed Anbar
Contact information
Scientific
Sohag University
Sohag University Road
Naser City
Sohag
82511
Egypt
Study information
| Study design | Prospective single centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effect of different incision sites of phacoemulsification on trabeculectomy bleb function: Prospective case-control study |
| Study objectives | The aim of this study was to compare superior and temporal clear corneal incisions of uneventful phacoemulsification and in-the-bag intraocular lens implantation on intraocular pressure control and the bleb morphology in eyes that have undergone previous successful trabeculectomy. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Cataract and glaucoma |
| Intervention | Participants who previously undergone trabeculectomy without antimetabolites are consecutively allocated (1:1) to one of two groups. Group 1 (Temporal group): Participants in this group undergo phacoemulsification with a temporal corneal incision. Group 2 (Superior group): Participants in this group undergo phacoemulsification with a superior corneal incision. Comparisons between the two groups are performed after one year of follow-up regarding intraocular pressure changes, bleb morphology score using the Wuerzburg bleb classification score and any added glaucoma medications. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Intraocular pressure changes is measured using the Goldman tonometer … at day one, one week, one month, three months, six months, and one year postoperatively 2. Bleb morphology score is measured using the Wuerzburg bleb classification score at day one, one week, one month, three months, six months, and one year postoperatively 3. Additional glaucoma medications are measured using patient's records up to one year postoperatively |
| Secondary outcome measures | There are no secondary outcome measures. |
| Overall study start date | 15/10/2014 |
| Completion date | 15/01/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Previous successful trabeculectomy not augmented by antimetabolites and had well-controlled IOP 2. Well-functioning bleb, no preoperative glaucoma medications 3. A visually significant cataract before phacoemulsification 4. Aged 18 and older |
| Key exclusion criteria | 1. Patients with primary angle closure glaucoma, 2. Secondary glaucoma 3. Associated eye diseases 4. Preoperative antimetabolite use 5. Posterior capsule rupture and/or vitreous loss during phacoemulsification |
| Date of first enrolment | 15/12/2014 |
| Date of final enrolment | 15/06/2015 |
Locations
Countries of recruitment
- Egypt
Study participating centre
Sohag
002
Egypt
Sponsor information
Hospital/treatment centre
Sohag University Road
Naser City
Sohag
82511
Egypt
"ROR" |
https://ror.org/02wgx3e98 |
|---|
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 15/01/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication and dissemination plan and intention to publish date planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from (manber2006@yahoo.com) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/06/2017 | 26/11/2020 | Yes | No |
Editorial Notes
26/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
