CataractNCT01334658
Study of Corneas Undergoing Balanced Salt Solution(BSS ®) Versus Glucose-bicarbonate-Ringer Lactate in Cataract Surgery
A study testing Phacoemulsification cataract surgery, Glucose-bicarbonate-Ringer Lactate (GBRL) and Balanced Salt Solution (BSS®) in people with Cataract, run by Grupo de Estudos em Oftalmologia Clínica e Cirúrgica.
Trial summary
This is a study aimed at evaluating the effectiveness and impact of two intraocular irrigating solution (BSS ® versus glucose-bicarbonate-Ringer Lactate - GBRL) on the health of the cornea after cataract surgery by phacoemulsification. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cataract
- What is being tested?
- Phacoemulsification cataract surgery, Glucose-bicarbonate-Ringer Lactate (GBRL) and Balanced Salt Solution (BSS®)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uncomplicated senile cataract
- Visual acuity (VA) between 20/40 and 20/400
- Healthy corneas
Who cannot join
- Mental incapacity
- Patients with coexisting diseases of the cornea
- Presence of corneal opacity
- Uncontrolled glaucoma
- Uncontrolled diabetes mellitus
- Uveitis
Show all 10Show fewer
- Cells or flare in the anterior chamber
- Prior intraocular surgery
- Patients using topical steroids or systemic
- Traumatic cataract, hereditary or toxic
About this study
Official title: Study of Endothelial Cell Density of Corneas Undergoing Phacoemulsification Surgery Using Balanced Salt Solution (BSS ®) Versus Glucose-bicarbonate-Ringer Lactate as Irrigating Solution: a Randomized Clinical Trial.
This is a study aimed at evaluating the effectiveness and impact of two intraocular irrigating solution (BSS ® versus glucose-bicarbonate-Ringer Lactate - GBRL) on the health of the cornea after cataract surgery by phacoemulsification.
- Conditions
- Cataract
- Being tested
- Phacoemulsification cataract surgery, Glucose-bicarbonate-Ringer Lactate (GBRL), Balanced Salt Solution (BSS®)
- Keywords
- Corneal endothelium, Cataract surgery, Irrigation solutions intraocular, Phacoemulsification
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification cataract surgeryProcedure or surgery
A group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) [500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)] as a solution for irrigation during surgery.
All surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation [BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..).
Glucose-bicarbonate-Ringer Lactate (GBRL)Drug
A group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) [500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)] as a solution for irrigation during surgery.
All surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation [BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..).
Balanced Salt Solution (BSS®)Drug
A group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) [500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)] as a solution for irrigation during surgery.
All surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation [BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..).
| Study group | Role | What they receive |
|---|---|---|
| Balanced Salt Solution (BSS®) | Active comparator | Subjects who received Balanced Salt Solution. Receives: Procedure: Phacoemulsification cataract surgery; Drug: Balanced Salt Solution (BSS®) |
| Glucose-bicarbonate-Ringer Lactate (GBRL) | Active comparator | Subjects who received glucose-bicarbonate-Ringer Lactate. Receives: Procedure: Phacoemulsification cataract surgery; Drug: Glucose-bicarbonate-Ringer Lactate (GBRL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in central corneal thickness (CCT)
Measured: Two days after surgery.
Increase in central corneal thickness (CCT)
Measured: Thirty days after surgery.
Increase in central corneal thickness (CCT)
Measured: Ninety days after surgery.
Decrease in the percentage of endothelial cell density (ECD)
Measured: Two days after surgery.
Decrease in the percentage of endothelial cell density (ECD)
Measured: Thirty days after surgery.
Decrease in the percentage of endothelial cell density (ECD)
Measured: Ninety days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startAug 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo de Estudos em Oftalmologia Clínica e Cirúrgica
- Sponsor type
- University, hospital or other
- Collaborators
- CLIHON
- Investigators
- Hermelino L Oliveira Neto, Study director, CLIHONIsrael C Marques Neto, Principal investigator, State University of Feira de Santana (UEFS)Brunno B Barros, Principal investigator, State University of Feira de Santana (UEFS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334658
- Sponsor's protocol ID
- 100
- Status last verified
- Apr 2011
- First submitted
- 8 Apr 2011
- Last updated
- 13 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Endothelial Cell Density of Corneas Undergoing Phacoemulsification Surgery Using Balanced Salt Solution (BSS ®) Versus Glucose-bicarbonate-Ringer Lactate as Irrigating Solution: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01334658
- Acronym / sponsor ID
- 100
- Conditions
- Cataract
- Keywords
- Corneal endothelium, Cataract surgery, Irrigation solutions intraocular, Phacoemulsification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Grupo de Estudos em Oftalmologia Clínica e CirúrgicaUniversity, hospital or other
- Collaborators
- CLIHON
- Study start
- Aug 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 13 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study aimed at evaluating the effectiveness and impact of two intraocular irrigating solution (BSS ® versus glucose-bicarbonate-Ringer Lactate - GBRL) on the health of the cornea after cataract surgery by phacoemulsification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balanced Salt Solution (BSS®) | Active comparator | Procedure: Phacoemulsification cataract surgery, Drug: Balanced Salt Solution (BSS®)Subjects who received Balanced Salt Solution. |
| Glucose-bicarbonate-Ringer Lactate (GBRL) | Active comparator | Procedure: Phacoemulsification cataract surgery, Drug: Glucose-bicarbonate-Ringer Lactate (GBRL)Subjects who received glucose-bicarbonate-Ringer Lactate. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Uncomplicated senile cataract
- Visual acuity (VA) between 20/40 and 20/400
- Healthy corneas
Key exclusion criteria (10 listed)
- Mental incapacity
- Patients with coexisting diseases of the cornea
- Presence of corneal opacity
- Uncontrolled glaucoma
- Uncontrolled diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phacoemulsification cataract surgeryA group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) [500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)] as a solution for irrigation during surgery. All surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation [BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..). | Procedure or surgery | Balanced Salt Solution (BSS®), Glucose-bicarbonate-Ringer Lactate (GBRL) |
| Glucose-bicarbonate-Ringer Lactate (GBRL)A group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) [500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)] as a solution for irrigation during surgery. All surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation [BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..). | Drug | Glucose-bicarbonate-Ringer Lactate (GBRL) |
| Balanced Salt Solution (BSS®)A group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) [500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)] as a solution for irrigation during surgery. All surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation [BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..). | Drug | Balanced Salt Solution (BSS®) |
Primary outcome
Increase in central corneal thickness (CCT)
Time frame: Two days after surgery.
Increase in central corneal thickness (CCT)
Time frame: Thirty days after surgery.
Increase in central corneal thickness (CCT)
Time frame: Ninety days after surgery.
Decrease in the percentage of endothelial cell density (ECD)
Time frame: Two days after surgery.
Decrease in the percentage of endothelial cell density (ECD)
Time frame: Thirty days after surgery.
Decrease in the percentage of endothelial cell density (ECD)
Time frame: Ninety days after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hermelino L Oliveira Neto study director
CLIHON
Israel C Marques Neto principal investigator
State University of Feira de Santana (UEFS)
Brunno B Barros principal investigator
State University of Feira de Santana (UEFS)
Questions about this trial
What is this clinical trial studying?
A study testing Phacoemulsification cataract surgery, Glucose-bicarbonate-Ringer Lactate (GBRL) and Balanced Salt Solution (BSS®) in people with Cataract, run by Grupo de Estudos em Oftalmologia Clínica e Cirúrgica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in central corneal thickness (CCT) (time frame: Two days after surgery.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2011.