Plain English Summary
Background and study aims
Cataract is a disease where the natural lens of the eye becomes opaque instead of clear. It has many causes, but mostly occurs as part of aging. It requires a surgery to replace the opaque natural lens with a clear artificial one. Glaucoma is a disease where the fluids inside the eyes are entrapped. This will raise the pressure inside the eye and will gradually damage the eye nerve, responsible for image transmission to the brain. The damage is gradual but permanent. If the eye pressure is not controlled, it might eventually lead to complete blindness. There are different types of glaucomas, depending on the cause and the location of fluid entrapment. If the cause is unknown, it is called primary. If the location is just outside the eye, and the structure is apparently normal, it is called open angle. Primary open angle glaucoma is one of the most common and serious causes of blindness in the modern world. To treat glaucoma you need to stop the damage of the nerve by controlling the pressure. Eye pressure control is first tried by medications, in the form of eye drops. One or more (up to 3) types of drops could be used for pressure control. However, surgery might be used to obtain the same results if the pressure is still not under control after using the maximum number of drugs. The simple idea of the surgery is to create a path for the entrapped fluid to exit the eye at an acceptable rate (not too slow, not too fast). This can be made by a "trap-door" that exits under the fine membrane covering the white of the eye (called conjunctiva). The conjunctiva might try to heal and return to its original status. This will cause fibrosis and closure of the trap-door, ending in failure of the surgery. There are several ways to prevent fibrosis. The most famous way is to use a medication called mitomycin-C (MMC), originally used in cancer, which prevent fibrosis. Another method is to preserve the space over the trap-door by placing a special type of medically prepared sponge (OlogenTM), which takes 6 months to dissolve. During these 6 months, the healing will complete and fibrosis will stop. It will leave a space "reservoir", where entrapped fluids can find their way out. Each of the methods has its own advantages and disadvantages (failure and complications). Both diseases, cataract and glaucoma, might occur in the same individual. The aim of this study is to find out which treatment is better to use, MMC or OlogenTM, in surgeries to treat cataract and glaucoma at the same time.
Who can participate?
Patients with cataract and primary open angle glaucoma not controlled by medical treatment
What does the study involve?
In this study, patients have a combined surgery for cataract and glaucoma. One third of the patients have the glaucoma surgery with MMC. One third of the patients have surgery with OlogenTM. Another third have the glaucoma surgery with both methods but with half the dose of MMC. Eye pressure control is assessed before surgery and 1 day, 1 week , 1, 3, 6, 9 and 12 months after surgery.
What are the possible benefits and risks of participating?
The possible benefit of participating is complete cure of both cataract and glaucoma. The possible risk is the occurrence of complications during or after the surgery as an example but not limited to: infection, failure to control eye pressure, or bleeding. These complications have the same chance of occurring as having the same surgery outside of the trial.
Where is the study run from?
1. Magrabi Eye Hospital (Egypt)
2. The Eye Consultants Center (Saudi Arabia)
When is the study starting and how long is it expected to run for?
November 2013 to March 2017
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Dr Momen Hamdi
mo2_76@hotmail.com
2. Dr Islam Hamdi
islammhamdi@hotmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Momen Hamdi
ORCID ID
http://orcid.org/0000-0003-2932-8248
Contact details
10 Hassan El Imam St.
Nasr City
Cairo
11371
Egypt
+20 (0)1223532717
mo2_76@hotmail.com
Type
Public
Additional contact
Dr Islam Hamdi
ORCID ID
http://orcid.org/0000-0002-9864-3471
Contact details
The Eye Consultants
PO Box 15637
Jeddah
21454
Saudi Arabia
+966 (0)556888136
islammhamdi@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
002-13
Study information
Scientific title
The role of Mitomycin C and OlogenTM in phacotrabeculectomy
Acronym
MMC and OlogenTM in Phacotrabe
Study hypothesis
Using both MMC and OlogenTM avoids complications of both and improves results in phacotrabeculectomy.
Ethics approval
1. Magrabi Eye Hospital, Cairo, Egypt, 24/9/2013 (no reference number available)
2. The Eye Consultants Center, Jeddah, Saudi Arabia, 11/11/2013 (no reference number available)
Study design
Prospective interventional comparative study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Surgical treatment for concomitant cataract and glaucoma
Intervention
Patients suffering from concomitant visually significant cataract and medically uncontrolled glaucoma, will undergo a combined procedure: cataract extraction and intraocular lens implantation (phacoemulsification and IOL) + glaucoma filtration surgery (trabeculectomy). The procedure is collectively known as "Phacotrabe". Phaco surgery is standard, while Trabe can be enhanced by various agents. The first agent is Mitomycin C: a drug used in treatment of tumors, that prevents cell replication. It prevents fibrosis of tissue that lead to failure of the surgery. OlogenTM is a biodegradable sponge. It is applied at the outlet of the path created by the surgery. It maintains the space for about 6 months, until the fibrosis procedure completes, sparing the area of the sponge and maintaining an open path.
Patients will be divided into three groups equally. Patients will be recruited consecutively, according to timing of surgery, into the three groups. All will receive phaco procedure. The first group will undergo trabe using full dose MMC (0.2 mg/ml for 3 min). The second group will undergo trabe with OlogenTM. The third group will undergo trabe with OlogenTM + low dose MMC (0.2 mg/ml for 90 sec).
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Intraocular pressure (IOP) control after surgery assessed using Goldman Tonometer at every examination: preoperative and postoperative 1 day, 1 week , 1, 3, 6, 9 and 12 months
Secondary outcome measures
1. Complications will be assessed during post-operative slit lamp examination after surgery at day 1, week 1 and month 1. These complications are: Hypotony (IOP <6 mmHg), shallow anterior chamber (iris and cornea touching) and significant hyphaema (bleeding inside the front part of the eye)
2. Number of postoperative medications needed to lower IOP, success in IOP control and the presence of blood vessels at site of surgery (bleb vascularity) will be assessed at 12 months:
2.1. Number of postoperative medications needed to lower IOP is assessed as follows: the use of one medication entails use of B-blockers eye drops twice a day. The use of two medications means combination of B-Blockers and Dorzolamide eye drops, twice a day. Three medications means the addition of Latanoprost eye drops, once at night time to the previous 2 medications
2.2. Success of IOP control is considered to be “Complete” with IOP < 21 mmHg without any additional topical medication. “Qualified” success considered with IOP < 21 mmHg with additional topical medication. “Failure” is considered with IOP > 21 mmHg despite maximum medications
2.3. The presence of blood vessels at site of surgery is detected by slit lamp examination and is graded by a five scaling score, where: Grade 0: no vessels at site of surgery. Grade 1: no vessels are present but there are small cysts and tissues are clear. Grade 2: few vessels are present (similar to adjacent tissues). Grade 3: moderate number of vessels. Grade 4: too many vessels
Overall trial start date
18/11/2013
Overall trial end date
31/03/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients having clinically significant cataract affecting best corrected visual acuity (BCVA) worse than 6/24 on Snellen’s chart, together with Primary Open Angle Glaucoma (POAG) where IOP was not controlled by medical treatment (more than 21 mmHg despite maximally tolerated medications).
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Other eye diseases (e.g. cornea, retina, etc)
2. Other forms of glaucoma than POAG (e.g. angle closure glaucoma, secondary glaucoma and congenital glaucoma)
3. Previous procedure for treatment of glaucoma (laser or previous surgery)
Recruitment start date
18/12/2013
Recruitment end date
20/03/2016
Locations
Countries of recruitment
Egypt, Saudi Arabia
Trial participating centre
Magrabi Eye Hospital
Al Sayeda Nafisa, El Khalifa, El-Sayeda Zainab
Cairo
11617
Egypt
Trial participating centre
The Eye Consultants Center
Al Nahda Alhadeetha
PO Box 15637
Jeddah
21454
Saudi Arabia
Sponsor information
Organisation
Magrabi Eye Hospital
Sponsor details
Al Sayeda Nafisa
El Khalifa
El-Sayeda Zainab
Cairo
11617
Egypt
Sponsor type
Hospital/treatment centre
Website
Organisation
The Eye Consultants Center
Sponsor details
PO Box 15637
Jeddah
21454
Saudi Arabia
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The final manuscript will be presented to specialized medical journals (e.g. Journal of Ophthalmology), to share the results with the medical community.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Momen Hamdi (Mo2_76@hotmail.com). Data would be preserved for 3 years after publishing the results and available for inquiries. As per the signed informed consent signed before participation and according to the approval of ethical committees, only clinical data (like vision and IOP levels) of relevance can be released. Personal data that can identify participants like names and addresses will not be released.
Intention to publish date
28/02/2019
Participant level data
Available on request
Basic results (scientific)
Publication list