Punctal Plugs and Iodine Related Discomfort
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/22/2018 |
| Start Date: | July 26, 2017 |
| End Date: | December 7, 2018 |
| Contact: | Marlena Daniels, COA |
| Email: | madaniels@eyenm.com |
| Phone: | (505) 343-6093 |
The Use of Punctal Plugs in Reducing Iodine Related Ocular Surface Discomfort
Purpose: Intravitreal injection of medications has revolutionized the treatment microvascular
diseases. These diseases often require regular, life-long injections. Ensuring patient
comfort is important for compliance with long-term treatments. Patients receiving regular
intravitreal injections often complain of progressive dry eye related discomfort. These
symptoms are likely secondary to the use of povidone iodine as an antiseptic. Investigators
hypothesize that punctal plugs could reverse the progressive ocular surface discomfort
induced by povidone iodine during the post-procedural state.
diseases. These diseases often require regular, life-long injections. Ensuring patient
comfort is important for compliance with long-term treatments. Patients receiving regular
intravitreal injections often complain of progressive dry eye related discomfort. These
symptoms are likely secondary to the use of povidone iodine as an antiseptic. Investigators
hypothesize that punctal plugs could reverse the progressive ocular surface discomfort
induced by povidone iodine during the post-procedural state.
Retina specialists treat many diseases of the posterior segment of the eye by the delivery of
medications via intravitreal injections. Many of these medications are monoclonal antibodies
that need to be injected monthly. Endophthalmitis is a sight threatening complication of
intravitreal injections. Limiting this complication is of primary importance in any injection
protocol. The gold standard antiseptic used in intravitreal injection is Povidone-iodine
(PI). PI is used to clean the surrounding ocular adnexa and is used in a 5% dilution on the
ocular surface.
PI has been shown to be corrosive to the cornea, delay healing, and cause patients
significant discomfort post injection especially for those with dry eye. Non-steroidal
anti-inflammatories, topical anesthetics, and anticholinergics have been shown to decrease
post injection discomfort1, but these measures are expensive, do not protect against corneal
irritation and do not improve the healing capacity of the eye. There is a need for a cost
effective measure that can reduce corneal irritation and improve healing due to the effects
of PI. Punctal plugs are FDA approved for the treatment of dry eye. They increase lubrication
of the eye by blocking the drainage of tears into the lacrimal sac. Our study would like to
investigate the efficacy of punctal plug insertion in the prevention of dry eye symptoms
caused by PI following intravitreal injection.
It has been shown that PI is toxic to the cornea at increasing concentrations. Once in
contact with corneal epithelium it releases free iodine radicals causing cytotoxicity and
apoptosis of cells. This makes it an effective antiseptic for Ophthalmologic procedures, but
also causes significant destruction of the healthy corneal tissue2. It has also been shown in
rabbits that calf serum is protective against PI induced corneal damage by providing an
additional organic substrate for the PI to bind3. It is possible that natural tears can have
a similar effect.
Punctal plugs are an extremely cost effective and widely used device to increase the volume
of tears on the ocular surface. They block the lacrimal puncta and canalicular system that
drains into the nasolacrimal duct, thereby inhibiting drainage of the natural tears into the
nasal atria. In patients with dry eye who receive intravitreal injection punctal plugs may be
useful in reducing corneal irritation by increasing the volume of natural tears on the ocular
surface, which provides an additional organic substrate for the PI solution to bind. This has
the potential to decrease the corrosive effects of the PI on the cornea, reduce healing time,
and reduce pain in patients with dry eye.
Investigators will be performing a case crossover study. First patients who consent will be
asked to complete an Ocular Surface Disease Index (OSDI). Those whose score indicates a
diagnosis of dry eye will eligible for the study. Three to five days after their intravitreal
injection, patients will be contacted over the telephone and asked to complete the OSDI. At
their next visit, one month later, a punctal plug will be inserted before their second
injection. Three to five days after their second injection, they will be asked to complete
the OSDI over the telephone. At their third visit they will receive an intravitreal injection
and three to five days after they will be asked to complete a final OSDI. If patients are
receiving bilateral intravitreal injections, and the OSDI survey indicates dry eyes
bilaterally, then only one of the eyes will be randomly chosen for plug insertion. The other
eye will then be used as a control. There will be no blinding.
medications via intravitreal injections. Many of these medications are monoclonal antibodies
that need to be injected monthly. Endophthalmitis is a sight threatening complication of
intravitreal injections. Limiting this complication is of primary importance in any injection
protocol. The gold standard antiseptic used in intravitreal injection is Povidone-iodine
(PI). PI is used to clean the surrounding ocular adnexa and is used in a 5% dilution on the
ocular surface.
PI has been shown to be corrosive to the cornea, delay healing, and cause patients
significant discomfort post injection especially for those with dry eye. Non-steroidal
anti-inflammatories, topical anesthetics, and anticholinergics have been shown to decrease
post injection discomfort1, but these measures are expensive, do not protect against corneal
irritation and do not improve the healing capacity of the eye. There is a need for a cost
effective measure that can reduce corneal irritation and improve healing due to the effects
of PI. Punctal plugs are FDA approved for the treatment of dry eye. They increase lubrication
of the eye by blocking the drainage of tears into the lacrimal sac. Our study would like to
investigate the efficacy of punctal plug insertion in the prevention of dry eye symptoms
caused by PI following intravitreal injection.
It has been shown that PI is toxic to the cornea at increasing concentrations. Once in
contact with corneal epithelium it releases free iodine radicals causing cytotoxicity and
apoptosis of cells. This makes it an effective antiseptic for Ophthalmologic procedures, but
also causes significant destruction of the healthy corneal tissue2. It has also been shown in
rabbits that calf serum is protective against PI induced corneal damage by providing an
additional organic substrate for the PI to bind3. It is possible that natural tears can have
a similar effect.
Punctal plugs are an extremely cost effective and widely used device to increase the volume
of tears on the ocular surface. They block the lacrimal puncta and canalicular system that
drains into the nasolacrimal duct, thereby inhibiting drainage of the natural tears into the
nasal atria. In patients with dry eye who receive intravitreal injection punctal plugs may be
useful in reducing corneal irritation by increasing the volume of natural tears on the ocular
surface, which provides an additional organic substrate for the PI solution to bind. This has
the potential to decrease the corrosive effects of the PI on the cornea, reduce healing time,
and reduce pain in patients with dry eye.
Investigators will be performing a case crossover study. First patients who consent will be
asked to complete an Ocular Surface Disease Index (OSDI). Those whose score indicates a
diagnosis of dry eye will eligible for the study. Three to five days after their intravitreal
injection, patients will be contacted over the telephone and asked to complete the OSDI. At
their next visit, one month later, a punctal plug will be inserted before their second
injection. Three to five days after their second injection, they will be asked to complete
the OSDI over the telephone. At their third visit they will receive an intravitreal injection
and three to five days after they will be asked to complete a final OSDI. If patients are
receiving bilateral intravitreal injections, and the OSDI survey indicates dry eyes
bilaterally, then only one of the eyes will be randomly chosen for plug insertion. The other
eye will then be used as a control. There will be no blinding.
Inclusion Criteria:
- Patients seen at Eye Associates of New Mexico Retina Center or the University of New
Mexico Eye Clinic
- Three consecutive monthly intravitreal injections
- Patients whose OSDI score indicate dry eye (score greater than 12)
- Greater than 18 years old
- Males and Females
Exclusion Criteria:
- previous punctal plugs
- punctal cautery
- active infection
- history of ocular infection
1. herpes simplex virus
2. herpes zoster virus
- previous eyelid trauma
1. surgery
2. graft versus host disease
3. and thyroid eye disease
- Women whom are pregnant or may become pregnant
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