Trial Outcomes & Findings for Optimal Method for Mydriasis in Cataract Surgery (NCT NCT02909140)

Results Overview

Pupil size immediately prior to the capsulorrhexis step of cataract surgery. This will be recorded by digital photography and measured by a researcher who is masked to the intervention.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

Immediately prior to the capsulorrhexis step of cataract surgery

Results posted on

2019-09-10

Participant Flow

Although 3 patients were enrolled, no information is available for the 3rd patient. Hence, the discrepancy.

Participant milestones

Participant milestones
Measure	Topical Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1%	Intracameral Mydriasis Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000	Topical + Intracameral Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000
Overall Study STARTED	0	2	0
Overall Study COMPLETED	0	2	0
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topical Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1%	Intracameral Mydriasis n=2 Participants Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000	Topical + Intracameral Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=2 Participants	—	0 Participants n=2 Participants
Age, Categorical Between 18 and 65 years	—	0 Participants n=2 Participants	—	0 Participants n=2 Participants
Age, Categorical >=65 years	—	2 Participants n=2 Participants	—	2 Participants n=2 Participants
Sex: Female, Male Female	—	1 Participants n=2 Participants	—	1 Participants n=2 Participants
Sex: Female, Male Male	—	1 Participants n=2 Participants	—	1 Participants n=2 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Systolic blood pressure in preoperative area	—	144 mmHg n=2 Participants	—	144 mmHg n=2 Participants
Heart rate in preoperative area	—	75.5 bpm n=2 Participants	—	75.5 bpm n=2 Participants
Systolic blood pressure on entry to OR	—	172 mmHg n=2 Participants	—	172 mmHg n=2 Participants
Heart rate on entry to OR	—	80.5 bpm n=2 Participants	—	80.5 bpm n=2 Participants

PRIMARY outcome

Timeframe: Immediately prior to the capsulorrhexis step of cataract surgery

Population: Data was only collected for the "Intracameral Mydriasis' arm. We analyzed data for 1 participant only because of lack of data for the other participant.

Pupil size immediately prior to the capsulorrhexis step of cataract surgery. This will be recorded by digital photography and measured by a researcher who is masked to the intervention.

Outcome measures

Outcome measures
Measure	Topical Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1%	Intracameral Mydriasis n=1 Participants Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000	Topical + Intracameral Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000
Pupil Size Immediately Prior to Capsulorrhexis	—	8 mm	—

SECONDARY outcome

Timeframe: Immediately after nuclear disassembly step of cataract surgery

Population: Data was only collected for the "Intracameral Mydriasis' arm. We analyzed data for 1 participant only because of lack of data for the other participant.

Pupil size immediately after breaking up of cataractous lens

Outcome measures

Outcome measures
Measure	Topical Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1%	Intracameral Mydriasis n=1 Participants Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000	Topical + Intracameral Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000
Pupil Size (mm) Immediately After Nuclear Disassembly	—	8 mm	—

SECONDARY outcome

Timeframe: Immediately prior to IOL insertion step of cataract surgery

Population: Data was only collected for the "Intracameral Mydriasis' arm. We analyzed data for 1 participant only because of lack of data for the other participant.

Pupil size after insertion of IOL lens

Outcome measures

Outcome measures
Measure	Topical Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1%	Intracameral Mydriasis n=1 Participants Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000	Topical + Intracameral Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000
Pupil Size Immediately Prior to Intraocular Lens (IOL) Insertion	—	8 mm	—

SECONDARY outcome

Timeframe: intraoperative

Population: Data was only collected for the "Intracameral Mydriasis' arm. We analyzed data for 1 participant only because of lack of data for the other participant.

Outcome measures

Outcome measures
Measure	Topical Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1%	Intracameral Mydriasis n=1 Participants Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000	Topical + Intracameral Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000
Pupil Size Upon Completion of Surgery	—	7 mm	—

SECONDARY outcome

Timeframe: Post-operative Day 1

Population: Data not available because it wasn't collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: intraoperative

Population: Data was only collected for the "Intracameral Mydriasis' arm

Outcome measures

Outcome measures
Measure	Topical Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1%	Intracameral Mydriasis n=2 Participants Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000	Topical + Intracameral Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000
Percentage of Patients in Each Arm That Required Another Mydriatic Agent	—	0 percent of participants	—

SECONDARY outcome

Timeframe: During cataract surgery

Population: Data was only collected for the "Intracameral Mydriasis' arm. We analyzed data for 1 participant only because of lack of data for the other participant.

The amount of energy needed to break up the cataractous lens

Outcome measures

Outcome measures
Measure	Topical Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1%	Intracameral Mydriasis n=1 Participants Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000	Topical + Intracameral Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000
Cumulative Energy Dispersed for Each Arm	—	6.6 Percent-seconds	—

SECONDARY outcome

Timeframe: intraoperative

Population: Data was only collected for the "Intracameral Mydriasis' arm. We analyzed data for 1 participant only because of lack of data for the other participant.

Outcome measures

Outcome measures
Measure	Topical Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1%	Intracameral Mydriasis n=1 Participants Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000	Topical + Intracameral Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000
Mean Time Taken to Perform Phacoemulsification in Each Arm	—	76 seconds	—

SECONDARY outcome

Timeframe: Baseline

Population: Data not available because data was not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: intraoperative

Population: Data not available because data was not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During cataract surgery

Population: Data was only collected for the "Intracameral Mydriasis' arm We analyzed data for 1 participant only because of lack of data for the other participant.

Outcome measures

Outcome measures
Measure	Topical Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1%	Intracameral Mydriasis n=1 Participants Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000	Topical + Intracameral Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000
Mean Time Taken to Perform Phacoemulsification	—	76 seconds	—

SECONDARY outcome

Timeframe: intraoperative

Population: Data was only collected for the "Intracameral Mydriasis' arm

Outcome measures

Outcome measures
Measure	Topical Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1%	Intracameral Mydriasis n=2 Participants Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000	Topical + Intracameral Mydriasis Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Topical phenylephrine 2.5% Topical cyclopentolate 1% Intracameral Lidocaine 1% Intracameral 0.2- 0.3ml of epinephrine 1:10,000
Percentage of Patients in Each Arm That Required Use of an Iris Expansion Device During the Procedure	—	50 percent	—

Adverse Events

Topical Mydriasis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intracameral Mydriasis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Topical + Intracameral Mydriasis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Fasika Woreta

Wilmer Eye Institute

Phone: (410) 955-5650

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place