Macular HoleNCT00190164
Alleviated Positioning for Small Macular Holes
A study testing Macular hole surgery with alleviated positioning and Macular hole surgery with no alleviated positioning in people with Macular Hole, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Rational of the study: There are arguments to think that the closure of macular holes can be obtained without a strict positioning under certain conditions, i.e. hole size ≤ 400 µm, if the patient avoids the position laid down on the back. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Hole
- What is being tested?
- Macular hole surgery with alleviated positioning and Macular hole surgery with no alleviated positioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2005to Jun 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patient presenting an idiopathic macular hole of stage 2, 3 or 4
- Opening diameter of the macular hole ≤ 400 µm
- Patient having been informed of the objectives and constraints of the study and having signed an informed consent
- Patient not presenting a per-operational complication having required a complementary gesture or a modification of the usual procedure, with the only exception of discovering a retinal tear, flat, located between 10 and 2h and having required only a treatment by cryo.
Who cannot join
- Patient having a strong myopia of the eye operated (correction carried or optimal > 6 dioptres)
- Patient MONOPHTALMIA
- Patient presenting a non contact plan capsular CRYSTALLINE being able to leave a passage of gas towards the former segment
- Patient presenting an associated ocular pathology -
- Patient presenting a TM already operated of the eye to include (repetition or failure after a first surgery)
- Patient refusing to sign an assent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Success Rate of a Procedure Without Strict Positioning Post Surgical Versus With Positioning Face Towards the Strict Ground, at Patients Presenting a Macular Hole. Study of Non-Inferiority.
Rational of the study: There are arguments to think that the closure of macular holes can be obtained without a strict positioning under certain conditions, i.e. hole size ≤ 400 µm, if the patient avoids the position laid down on the back. In order to be able to confirm these observations, it is necessary to make a randomized study with an adequate number of patients.
Aim of the study: To show that the percentage of success (anatomical closure confirmed by OCT) is not lower in the group without positioning.
Read more
Tested Hypothesis: The absence of strict positioning is "at least as effective" on the success of the surgery of small macular holes as the imposition of a strict positioning.
Expected results: To show that the success rate of the surgery of the idiopathic macular holes of 400 µm or less is not decreased by the replacement of a strict positioning (face-down 22h/24) by a simple instruction of avoiding the position laid down on the back, thus avoiding the patients this painful part of the treatment and allowing a reduction in the duration of hospitalization and consequently a reduction in the cost of the treatment.
Read the detailed description
Rational of the study: There are arguments to think that the closure of macular holes can be obtained without a strict positioning under certain conditions, i.e. hole size ≤ 400 µm, if the patient avoids the position laid down on the back. In order to be able to confirm these observations, it is necessary to make a randomized study with an adequate number of patients.
Main Aim of the study: To show that the percentage of success (anatomical closure confirmed by OCT) is not lower in the group without positioning.
Tested Hypothesis: The absence of strict positioning is "at least as effective" on the success of the surgery of small macular holes as the imposition of a strict positioning.
Primary outcome: Frequency of the successes defined by anatomical closing.
Secondary objectives: To show the non inferiority of the technique without positioning by the following variables: - ETDRS visual acuity in the third postoperative month. - Progression of cataract - Frequency of the complications.
Design of the study: Randomized multicentric study, in parallel groups, open, with individual benefit for the patient.
Number of subjects and duration of the study: 68 patients, divided into two parallel groups, of more than 18 years, presenting a hole ≤ 400 µm, will be included and followed over a period of 3 months. The estimated total duration of the study is 27 months.
Data analysis: In the case of this equivalence clinical trial the margin of non inferiority was fixed at 15%. The secondary criteria will consequently be analyzed.
Expected results: To show that the success rate of the surgery of the idiopathic macular holes of 400 µm or less is not decreased by the replacement of a strict positioning (face-down 22h/24) by a simple instruction of avoiding the position laid down on the back, thus avoiding the patients this painful part of the treatment and allowing a reduction in the duration of hospitalization and consequently a reduction in the cost of the treatment.
- Conditions
- Macular Hole
- Being tested
- Macular hole surgery with alleviated positioning, Macular hole surgery with no alleviated positioning
- Keywords
- Macular hole, Vitrectomy, positioning, retina, surgery
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macular hole surgery with alleviated positioningProcedure or surgery
Macular hole surgery with alleviated positioning
Macular hole surgery with no alleviated positioningProcedure or surgery
Macular hole surgery with no alleviated positioning
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Macular hole surgery with alleviated positioning Receives: Procedure: Macular hole surgery with alleviated positioning |
| 2 | No intervention | Macular hole surgery with no alleviated positioning Receives: Procedure: Macular hole surgery with no alleviated positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of the successes defined by anatomical closure at third postoperative month.
Measured: during the 3 months
Secondary outcomes (3)
Gain of ETDRS visual acuity in the third postoperative month.
Measured: during the 3 months
Progression of cataract
Measured: during the 7 months
Frequency of the complications
Measured: during the 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionNov 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HoleStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Ramin TADAYONI, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190164
- Sponsor's protocol ID
- P031004
- Other IDs
- CRC03140
- Status last verified
- Jul 2007
- First submitted
- 12 Sep 2005
- Last updated
- 18 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Success Rate of a Procedure Without Strict Positioning Post Surgical Versus With Positioning Face Towards the Strict Ground, at Patients Presenting a Macular Hole. Study of Non-Inferiority.
- ClinicalTrials.gov ID
- NCT00190164
- Acronym / sponsor ID
- P031004
- Conditions
- Macular Hole
- Keywords
- Macular hole, Vitrectomy, positioning, retina, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 19 Sep 2005 (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.
Rational of the study: There are arguments to think that the closure of macular holes can be obtained without a strict positioning under certain conditions, i.e. hole size ≤ 400 µm, if the patient avoids the position laid down on the back. In order to be able to confirm these observations, it is necessary to make a randomized study with an adequate number of patients.
Aim of the study: To show that the percentage of success (anatomical closure confirmed by OCT) is not lower in the group without positioning.
Tested Hypothesis: The absence of strict positioning is "at least as effective" on the success of the surgery of small macular holes as the imposition of a strict positioning.
Expected results: To show that the success rate of the surgery of the idiopathic macular holes of 400 µm or less is not decreased by the replacement of a strict positioning (face-down 22h/24) by a simple instruction of avoiding the position laid down on the back, thus avoiding the patients this painful part of the treatment and allowing a reduction in the duration of hospitalization and consequently a reduction in the cost of the treatment.
Detailed description
Rational of the study: There are arguments to think that the closure of macular holes can be obtained without a strict positioning under certain conditions, i.e. hole size ≤ 400 µm, if the patient avoids the position laid down on the back. In order to be able to confirm these observations, it is necessary to make a randomized study with an adequate number of patients.
Main Aim of the study: To show that the percentage of success (anatomical closure confirmed by OCT) is not lower in the group without positioning.
Tested Hypothesis: The absence of strict positioning is "at least as effective" on the success of the surgery of small macular holes as the imposition of a strict positioning.
Primary outcome: Frequency of the successes defined by anatomical closing.
Secondary objectives: To show the non inferiority of the technique without positioning by the following variables: - ETDRS visual acuity in the third postoperative month. - Progression of cataract - Frequency of the complications.
Design of the study: Randomized multicentric study, in parallel groups, open, with individual benefit for the patient.
Number of subjects and duration of the study: 68 patients, divided into two parallel groups, of more than 18 years, presenting a hole ≤ 400 µm, will be included and followed over a period of 3 months. The estimated total duration of the study is 27 months.
Data analysis: In the case of this equivalence clinical trial the margin of non inferiority was fixed at 15%. The secondary criteria will consequently be analyzed.
Expected results: To show that the success rate of the surgery of the idiopathic macular holes of 400 µm or less is not decreased by the replacement of a strict positioning (face-down 22h/24) by a simple instruction of avoiding the position laid down on the back, thus avoiding the patients this painful part of the treatment and allowing a reduction in the duration of hospitalization and consequently a reduction in the cost of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Macular hole surgery with alleviated positioningMacular hole surgery with alleviated positioning |
| 2 | No intervention | Procedure: Macular hole surgery with no alleviated positioningMacular hole surgery with no alleviated positioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Patient presenting an idiopathic macular hole of stage 2, 3 or 4
- Opening diameter of the macular hole ≤ 400 µm
- Patient having been informed of the objectives and constraints of the study and having signed an informed consent
- Patient not presenting a per-operational complication having required a complementary gesture or a modification of the usual procedure, with the only exception of discovering a retinal tear, flat, located between 10 and 2h and having required only a treatment by cryo.
Key exclusion criteria (6 listed)
- Patient having a strong myopia of the eye operated (correction carried or optimal > 6 dioptres)
- Patient MONOPHTALMIA
- Patient presenting a non contact plan capsular CRYSTALLINE being able to leave a passage of gas towards the former segment
- Patient presenting an associated ocular pathology -
- Patient presenting a TM already operated of the eye to include (repetition or failure after a first surgery)
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 |
|---|---|---|
| Macular hole surgery with alleviated positioningMacular hole surgery with alleviated positioning | Procedure or surgery | 1 |
| Macular hole surgery with no alleviated positioningMacular hole surgery with no alleviated positioning | Procedure or surgery | 2 |
Primary outcome
Frequency of the successes defined by anatomical closure at third postoperative month.
Time frame: during the 3 months
3 secondary outcomes
Gain of ETDRS visual acuity in the third postoperative month.
Time frame: during the 3 months
Progression of cataract
Time frame: during the 7 months
Frequency of the complications
Time frame: during the 7 months
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 18 Jul 2008.
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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.
Ramin TADAYONI, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macular hole surgery with alleviated positioning and Macular hole surgery with no alleviated positioning in people with Macular Hole, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 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 18 Jul 2008. 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 France. 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?
Frequency of the successes defined by anatomical closure at third postoperative month. (time frame: during the 3 months). 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 18 Jul 2008.