GlaucomaNCT00695747
Intraocular Pressure Control Following One Site Versus Two Site Combined Phacoemulsification/IOL And Trabeculectomy
A study testing 2 Site procedure- Phacoemulsification/IOL and Trabeculectomy in people with Glaucoma and Cataracts, run by Lahey Clinic at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety \& effectiveness of the two types of cataract and glaucoma surgeries. Results from this study may improve the surgical and post surgical management and long term management of patients with these conditions in the future Read more about this study
- Who is it for?
- Any age
- What is being tested?
- 2 Site procedure- Phacoemulsification/IOL and Trabeculectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1998to Jan 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Meet the current criteria for combined procedure surgery:
- A visually significant cataract(ie: an opacification of the crystalline lens resulting in a reduction of visual performance affecting daily living
- Open angle or mixed mechanism glaucoma inadequately controlled on current therapy, or requiring two or more medications for control, or with advanced visual field and optic nerve damage.
Who cannot join
- Subjects with normal tension glaucoma(defined as those subjects in whom no IOPs greater than 21 mm Hg[preceding or during therapy]have been recorded)
- Subjects with uveitis
- Subjects with neovascular glaucoma
- Severe conjunctival inflammation or scarring
- Subjects who have had previous incisional ocular surgery in the same eye
- No subjects will have second eye operated on within 8 weeks of the first eye
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the safety \& effectiveness of the two types of cataract and glaucoma surgeries. Results from this study may improve the surgical and post surgical management and long term management of patients with these conditions in the future
Read the detailed description
The purpose of this study is to determine whether a Two-Site Technique for the Combined Procedure for subjects with coexisting visually significant glaucoma \& cataracts will result in an improvement in IOP control in both the immediate and longer term postoperative period as compared with the currently Standard One Site surgical technique for both glaucoma and cataracts.
Research and data indicate that the success rate of the glaucoma part of this operation may be improved if the incision for the cataract part of the operation is separated from the drainage hole created for the glaucoma part, the constant drainage through this hole is what lowers the intraocular pressure after surgery. Using the Two-Site Combined procedure the glaucoma incision(drainage hole) will still be created superiorly, under the upper lid. The cataract incision will be moved to the temporal side of the eye ball, away from the drainage hole for the glaucoma.
- Being tested
- 2 Site procedure- Phacoemulsification/IOL and Trabeculectomy
- Keywords
- Glaucoma, Cataracts, Phacoemulsification(IOL), Trabeculectomy
- Medical subject headings
- Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 Site procedure- Phacoemulsification/IOL and TrabeculectomyProcedure or surgery
Also called Coexisting Cataract and glaucoma, Cateract, Glaucoma, Phacoemulsification/IOL
2 Site Combined Procedure: in which a temporal clear cornea approach would be used for the cataract/IOL part of the procedure, and immediately thereafter the superior limbus would be employed for a limbus-based trabeculectomy
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Standard 1 site Procedure using a fornix based incision, performed superiorly |
| 2 | Experimental | 2 Site Combined Procedure Receives: Procedure: 2 Site procedure- Phacoemulsification/IOL and Trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Op outcomes of IOP less than or equal to 16mm Hg without additional ocular hypotensive medications
Measured: Assessments made at 3 months post op, 3 month intervals for at least 2 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startJan 1998
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies 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
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Paul R. Cotran, M.D., Principal investigator, Lahey Clinic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695747
- Sponsor's protocol ID
- 98-067
- Status last verified
- Jan 2009
- First submitted
- 10 Jun 2008
- Last updated
- 22 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Palmer SS. Mitomycin as adjunct chemotherapy with trabeculectomy. Ophthalmology. 1991 Mar;98(3):317-21. doi: 10.1016/s0161-6420(91)32293-0.
PubMed 2023752Shingleton BJ, Jacobson LM, Kuperwaser MC. Comparison of combined cataract and glaucoma surgery using planned extracapsular and phacoemulsification techniques. Ophthalmic Surg Lasers. 1995 Sep-Oct;26(5):414-9.
PubMed 8963855Gandolfi SA, Vecchi M. 5-fluorouracil in combined trabeculectomy and clear-cornea phacoemulsification with posterior chamber intraocular lens implantation. A one-year randomized, controlled clinical trial. Ophthalmology. 1997 Feb;104(2):181-6. doi: 10.1016/s0161-6420(97)30336-4.
PubMed 9052620Shin DH, Simone PA, Song MS, Reed SY, Juzych MS, Kim C, Hughes BA. Adjunctive subconjunctival mitomycin C in glaucoma triple procedure. Ophthalmology. 1995 Oct;102(10):1550-8. doi: 10.1016/s0161-6420(95)30832-9.
PubMed 9097805Joos KM, Bueche MJ, Palmberg PF, Feuer WJ, Grajewski AL. One-year follow-up results of combined mitomycin C trabeculectomy and extracapsular cataract extraction. Ophthalmology. 1995 Jan;102(1):76-83. doi: 10.1016/s0161-6420(95)31050-0.
PubMed 7831046Berestka JS, Brown SV. Limbus- versus fornix-based conjunctival flaps in combined phacoemulsification and mitomycin C trabeculectomy surgery. Ophthalmology. 1997 Feb;104(2):187-96. doi: 10.1016/s0161-6420(97)30335-2.
PubMed 9052621Scott IU, Greenfield DS, Schiffman J, Nicolela MT, Rueda JC, Tsai JC, Palmberg PF. Outcomes of primary trabeculectomy with the use of adjunctive mitomycin. Arch Ophthalmol. 1998 Mar;116(3):286-91. doi: 10.1001/archopht.116.3.286.
PubMed 9514480Parrish RK II, Folberg R. Wound healing in glaucoma surgery: In: Ritch R. Shields MB, Krupin T, eds. The Glaucomas 2nd ed. St. Louis: CV Mosby 1989, vol III, chap. 81
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Pressure Control Following One Site Versus Two Site Combined Phacoemulsification/IOL And Trabeculectomy
- ClinicalTrials.gov ID
- NCT00695747
- Acronym / sponsor ID
- 98-067
- Keywords
- Glaucoma, Cataracts, Phacoemulsification(IOL), Trabeculectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- Jan 1998
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 12 Jun 2008 (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.
The purpose of this study is to compare the safety \& effectiveness of the two types of cataract and glaucoma surgeries. Results from this study may improve the surgical and post surgical management and long term management of patients with these conditions in the future
Detailed description
The purpose of this study is to determine whether a Two-Site Technique for the Combined Procedure for subjects with coexisting visually significant glaucoma \& cataracts will result in an improvement in IOP control in both the immediate and longer term postoperative period as compared with the currently Standard One Site surgical technique for both glaucoma and cataracts.
Research and data indicate that the success rate of the glaucoma part of this operation may be improved if the incision for the cataract part of the operation is separated from the drainage hole created for the glaucoma part, the constant drainage through this hole is what lowers the intraocular pressure after surgery. Using the Two-Site Combined procedure the glaucoma incision(drainage hole) will still be created superiorly, under the upper lid. The cataract incision will be moved to the temporal side of the eye ball, away from the drainage hole for the glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Standard 1 site Procedure using a fornix based incision, performed superiorly |
| 2 | Experimental | Procedure: 2 Site procedure- Phacoemulsification/IOL and Trabeculectomy2 Site Combined Procedure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Meet the current criteria for combined procedure surgery:
- A visually significant cataract(ie: an opacification of the crystalline lens resulting in a reduction of visual performance affecting daily living
- Open angle or mixed mechanism glaucoma inadequately controlled on current therapy, or requiring two or more medications for control, or with advanced visual field and optic nerve damage.
Key exclusion criteria (6 listed)
- Subjects with normal tension glaucoma(defined as those subjects in whom no IOPs greater than 21 mm Hg[preceding or during therapy]have been recorded)
- Subjects with uveitis
- Subjects with neovascular glaucoma
- Severe conjunctival inflammation or scarring
- Subjects who have had previous incisional ocular surgery in the same eye
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 |
|---|---|---|
| 2 Site procedure- Phacoemulsification/IOL and TrabeculectomyAlso: Coexisting Cataract and glaucoma, Cateract, Glaucoma, Phacoemulsification/IOL2 Site Combined Procedure: in which a temporal clear cornea approach would be used for the cataract/IOL part of the procedure, and immediately thereafter the superior limbus would be employed for a limbus-based trabeculectomy | Procedure or surgery | 2 |
Primary outcome
Post-Op outcomes of IOP less than or equal to 16mm Hg without additional ocular hypotensive medications
Time frame: Assessments made at 3 months post op, 3 month intervals for at least 2 years post 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 22 Jan 2009.
- Background: PubMed 2023752Palmer SS. Mitomycin as adjunct chemotherapy with trabeculectomy. Ophthalmology. 1991 Mar;98(3):317-21. doi: 10.1016/s0161-6420(91)32293-0.
- Background: PubMed 8963855Shingleton BJ, Jacobson LM, Kuperwaser MC. Comparison of combined cataract and glaucoma surgery using planned extracapsular and phacoemulsification techniques. Ophthalmic Surg Lasers. 1995 Sep-Oct;26(5):414-9.
- Background: PubMed 9052620Gandolfi SA, Vecchi M. 5-fluorouracil in combined trabeculectomy and clear-cornea phacoemulsification with posterior chamber intraocular lens implantation. A one-year randomized, controlled clinical trial. Ophthalmology. 1997 Feb;104(2):181-6. doi: 10.1016/s0161-6420(97)30336-4.
- Background: PubMed 9097805Shin DH, Simone PA, Song MS, Reed SY, Juzych MS, Kim C, Hughes BA. Adjunctive subconjunctival mitomycin C in glaucoma triple procedure. Ophthalmology. 1995 Oct;102(10):1550-8. doi: 10.1016/s0161-6420(95)30832-9.
- Background: PubMed 7831046Joos KM, Bueche MJ, Palmberg PF, Feuer WJ, Grajewski AL. One-year follow-up results of combined mitomycin C trabeculectomy and extracapsular cataract extraction. Ophthalmology. 1995 Jan;102(1):76-83. doi: 10.1016/s0161-6420(95)31050-0.
- Background: PubMed 9052621Berestka JS, Brown SV. Limbus- versus fornix-based conjunctival flaps in combined phacoemulsification and mitomycin C trabeculectomy surgery. Ophthalmology. 1997 Feb;104(2):187-96. doi: 10.1016/s0161-6420(97)30335-2.
- Background: PubMed 9514480Scott IU, Greenfield DS, Schiffman J, Nicolela MT, Rueda JC, Tsai JC, Palmberg PF. Outcomes of primary trabeculectomy with the use of adjunctive mitomycin. Arch Ophthalmol. 1998 Mar;116(3):286-91. doi: 10.1001/archopht.116.3.286.
- BackgroundParrish RK II, Folberg R. Wound healing in glaucoma surgery: In: Ritch R. Shields MB, Krupin T, eds. The Glaucomas 2nd ed. St. Louis: CV Mosby 1989, vol III, chap. 81
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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.
Paul R. Cotran, M.D. principal investigator
Lahey Clinic, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 Site procedure- Phacoemulsification/IOL and Trabeculectomy in people with Glaucoma and Cataracts, run by Lahey Clinic at 1 site in United States.
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 6 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 22 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Post-Op outcomes of IOP less than or equal to 16mm Hg without additional ocular hypotensive medications (time frame: Assessments made at 3 months post op, 3 month intervals for at least 2 years post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00695747, which also lists 8 linked publications.
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 22 Jan 2009.